Systems and methods for the treatment of eye conditions

ABSTRACT

Systems, methods, and devices used to treat eyelids, meibomian glands, ducts, and surrounding tissue are described herein. In some embodiments, an eye treatment device is disclosed, which includes a scleral shield positionable proximate an inner surface of an eyelid, the scleral shield being made of, or coated with, an energy-absorbing material activated by a light energy, and an energy transducer positionable outside of the eyelid, the energy transducer configured to provide light energy at one or more wavelengths, including a first wavelength selected to heat the energy-absorbing material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/529,102 filed Oct. 30, 2014 and entitled “Systems and Methods for theTreatment of Eye Conditions”, and is a continuation in part ofco-pending U.S. patent application Ser. No. 14/265,228 filed Apr. 29,2014 and entitled “Systems and Methods for the Treatment of EyeConditions”, which claims the benefit of U.S. Provisional ApplicationNo. 61/817,757, filed Apr. 30, 2013. The priority to the filing dates ishereby claimed and the disclosures of the patent applications are herebyincorporated by reference in their entirety.

BACKGROUND Field of the Invention

The present disclosure relates to medical devices and methods of usingthe same. More particularly, the disclosure relates to systems, methods,and apparatus used to diagnose and treat conditions of the eye such asmeibomian gland dysfunction and blepharitis, typically involvingeyelids, meibomian glands, ducts, orifices, and surrounding tissue.

Description of the Related Art

Meibomian gland dysfunction (MGD) is thought to be the most common causeof evaporative dry eye disease, with studies showing a prevalenceranging from 20% to 60% in the general population. MGD is associatedwith a failure of meibomian glands to produce an adequate quantity ofnormal secretions (called meibum). Meibum is a lipid-rich essentialcomponent of a healthy tear film. When sufficient meibum is not presentin the tear film, the film readily evaporates, leading to evaporativedry eye disease. In some patients, the viscosity and melting point ofthe meibum may elevate, resulting in thickened meibum that does not floweasily out of the glands. Further, the channel or duct within themeibomian gland may become hyperkeratinized, leading to excessivecellular debris and contributing to the clogging of the gland over time.Once the glands become chronically clogged (inspissated), they mayatrophy, and no longer be able to produce or secrete meibum.

Blepharitis is a common chronic inflammatory condition involving theeyelid and eyelid margin, and is often associated with MGD. Studies showa prevalence of blepharitis in the general population ranging from 12%to 47%, with higher prevalence amongst older individuals. In addition tocertain causative factors relating to MGD, blepharitis may be caused inpart by an abundance of certain bacteria in and around the eye andeyelid. By-products of the bacteria are thought to be irritating to theeye, leading to further inflammation and discomfort to the patient. Inaddition, several types of common mites may play a role in adding to theinflammation of the meibomian glands or sebaceous glands in and aroundthe eyes. The inflammation caused by these factors can lead to furtherconstriction of the meibomian gland ducts, limiting the flow of meibumfrom the glands and aggravating the condition.

Diagnosis of meibomian gland dysfunction can be done in many ways.Typical approaches include measurement of tear break-up time (TBUT),staining of various ocular surfaces, and examination of the meibomianglands and their secretions. One common technique used to examine theglands themselves is to evert the eyelid and to place a light sourceunder the everted lid (on the outer surface of the lid) while examiningthe “transilluminated” image of the glands created by passing lightthrough the lid. The image may be observed by an unaided eye, through abiomicroscope, or with a camera. Healthy glands appear as long,relatively straight forms, while dysfunctional glands may appeartortuous and swollen, and atrophied glands show a lack of continuitybetween the gland mass and the duct or orifice. In certain cases,infrared light is projected onto or through the everted lid, and anIR-sensitive camera is used to view the meibomian glands. Thedisadvantage of these transillumination techniques is that they requirethe lid to be everted, which is uncomfortable for most patients, andwhich can be difficult for the clinician to perform on some eyelids.

Another common technique for diagnosing MGD is to apply pressure to theeyelid while observing the meibomian gland ducts or orifices along thelid margin, usually with a magnifying means such as a biomicroscope.Healthy glands produce a clear oily secretion in response to the appliedpressure. Glands that are partially dysfunctional produce less oiland/or cloudy oil. Glands that are more severely dysfunctional(inspissated) produce a paste-like secretion, which can only be squeezedout when more significant pressure is applied to the lid. Glands thatare completely atrophied or that have had their orifices occluded do notproduce any oil, even under high pressure.

MGD and blepharitis are chronic conditions with limited effectivetreatment. One of the most commonly recommended treatments is theapplication of a hot compress and massage (using the compress orfingertips) to the eyelid region. The intended goal of hot compresstreatment is to heat up inspissated meibomian glands where thickenedmeibum resides, causing the meibum to soften and thereby more easily beexpressed through the ducts. This process is thought to unclog the ductsand thereby allow the ducts to resume normal secretions and maintain ahealthier tear film. Patients are generally instructed to apply a hotwashcloth or other hot compress to the eyelid for five to ten minutes,multiple times daily. However, the efficacy of such an approach may belimited.

In-office treatment of MGD is often limited to squeezing the affectedeyelids in order to express meibum from clogged or inspissated glands.Most clinicians use their fingertip or a cotton swab to apply pressureto the outer lid surface, but sometimes they also use a swab or a flatmetal device (sometimes called a Mastrota paddle) on the inner lid whilepushing against the outer lid in order to squeeze meibum out. All ofthese techniques are cumbersome for clinicians and painful for mostpatients.

Another in-office treatment uses intense pulsed light (IPL) around theeyes and eyelids. Such treatments are said to produce an improvement indry eye symptoms over multiple sessions, but the mechanism is notunderstood and the equipment is expensive.

Still another in-office treatment is the TearScience LipiFlow(r) system,wherein heating elements are placed underneath the eyelids and anautomated external controller maintains the heating elements at a targettemperature while applying a predetermined pattern of compressionagainst the outer lids by way of inflatable bladders. This system isexpensive and does not allow the clinician to control the treatment suchto visually monitor the eyelid margin and meibomian gland ducts and tovary the level of heating and compression during the procedure in amanner that optimizes the treatment outcome. Such clinician control overthe treatment may be important and is not present in the TearSciencesystem.

Patients may also use saline drops or artificial tears to reduce thediscomfort associated with dry eye; however, this approach fails totreat the dysfunctional meibomian glands and underlying inflammation.Additionally or alternatively, antibiotics may be prescribed to reducethe bacterial load in and around the eyelid. Topical and oralantibiotics are available, including oral tetracycline derivatives,which reduce certain bacteria and provide a mild anti-inflammatoryeffect; however, the administration of antibiotics may cause sideeffects or adverse allergic reactions, and the approach is ofteninsufficient to provide significant long-term relief of blepharitis andMGD. Corticosteroids may be prescribed to reduce the inflammation;however, prolonged use of such steroids increases the risk ofdetrimental cortical lens changes, intraocular pressure spikes, andinfection due to immunosuppression.

A need therefore exists for improved methods and devices to diagnose andtreat meibomian gland dysfunction and blepharitis.

SUMMARY

Embodiments described herein may meet one or more of the needsidentified above and may overcome one or more of the shortcomings ofcurrent MGD and blepharitis treatment methods. Various implementationsof systems, methods, and devices within the scope of the appended claimseach have several aspects, no single one of which is solely responsiblefor the desirable attributes described herein. Without limiting thescope of the appended claims, some prominent features are describedherein.

The present application relates generally to treatment systems, methods,and devices used to treat eyelids, meibomian glands, ducts, andsurrounding tissue. Details of one or more implementations of thesubject matter described in this specification are set forth in theaccompanying drawings and the description below. Other features,embodiments, and advantages will become apparent from the description,the drawings, and the claims.

One aspect of this disclosure provides a device for treating an eyecondition in a mammal. In various embodiments, the device includes ascleral shield and an energy transducer. When the eyelid is positionedbetween the energy transducer and the scleral shield, the light energyfrom the energy transducer passes through the eyelid and heats theenergy-absorbing surface. Tissue adjacent to the energy-absorbingsurface is then warmed by conductive heating.

An additional aspect of the disclosure provides a method of treating aneye condition, for example, in a human or other mammal. The methodincludes positioning a scleral shield proximate an inner surface of aneyelid, the scleral shield being made of, or coated with, anenergy-absorbing material activated by light energy and positioning anenergy transducer outside of an eyelid of the mammal, the energytransducer configured to provide light energy at one or morewavelengths. The method also includes directing light energy from theenergy transducer toward the scleral shield at a first wavelengthselected to heat the energy-absorbing material and heating theenergy-absorbing material with the light energy to heat a target tissueregion sufficiently to melt meibum within meibomian glands locatedwithin or adjacent to the target tissue region.

In some embodiments, the energy transducer is further configured toprovide light energy at a second wavelength selected to be absorbed bythe eyelid tissue, and thereby heat the eyelid tissue. In someembodiments, the energy transducer is further configured to providelight energy at a third wavelength selected to treat bacteria. The firstwavelength may be in the range of about (without limitation) 700-1000nm, the second wavelength may be in the range of about (withoutlimitation) 400-700 nm and the third wavelength may be in the range ofabout (without limitation) 400-450 nm.

Some embodiments of the device further include an energy transmissionsurface slidably coupled to the energy transducer, wherein when theeyelid is positioned between the scleral shield and energy transmissionsurface during treatment, the movement of the energy transmissionsurface toward the scleral shield may contact and compress the eyelid.

Some embodiments of the device further include visualization means or avisualization device for viewing the eyelid during treatment.Additionally or alternatively, some embodiments of the device furtherinclude a reflective imager configured to view the inner surface of theeyelid with the visualization means. In some embodiments, viewing theinner surface of the eyelid includes transillumination of the eyelid andmeibomian glands.

In some embodiments, the energy-absorbing material of the scleral shieldmay be an infrared-absorbing material or surface made of black plasticor coated with a black substance, either of which may contain carbonblack (e.g. 5% or more) or other material which absorbs and/or heatswith infrared energy. The scleral shield may be a singular material or acomposite material comprising multiple layers (e.g. hydrogel, rigidplastic, soft plastic, metal, or glass).

In some embodiments, the energy transducer may include at least one ofan LED, laser, incandescent lamp, xenon lamp, halogen lamp, luminescentlamp, high-intensity discharge lamp, and gas discharge lamp.

In some embodiments, the target temperature range is between a minimumtemperature required to treat the eye condition and a maximumtemperature above which discomfort or thermal damage to the eye oreyelid may occur. In some such embodiments, the target temperature rangeis between about 40 and about 80 degrees Celsius.

Some embodiments of the device further include one or more componentsselected from the group consisting of: a display or dashboard configuredto display the device status; temperature measurement device or meansconfigured to measure various temperatures of the eyelid, such as innerand/or outer surface temperatures; a datalogger; a voice recorder; abattery configured to power the device components; battery chargingmeans; a controller; printed circuit board; and communication circuitrybetween scleral shield and energy transducer.

Some embodiments of the device further include a safety featureelectrically coupled to the energy transducer configured to prevent orinterrupt the light energy from the energy transducer if the if thescleral shield and associated assembly are not properly attached to, andaligned with, the device.

Additionally or alternatively, some embodiments of the device furtherinclude a timer operatively coupled to the energy transducer andconfigured to shut off the energy transducer after a predetermined time.In some embodiments, the device is configured to shut off the energytransducer upon the earlier of: waiting a predetermined length of time,and reaching a predetermined threshold for the temperature of theportion of the eyelid.

In some embodiments, heating the target tissue region includes softeningthe meibum in the meibomian glands. In some embodiments, the methodtreats at least one of blepharitis, dry eye, and meibomian glanddysfunction.

Another aspect of this disclosure provides a device for treating an eyecondition with the application of heat. In various embodiments, thedevice includes an energy transducer, a waveguide, a housing, and afirst safety sensor. The energy transducer is configured to emit lightenergy having wavelength characteristics selected to heat a targettissue region of an eyelid. The waveguide is positioned partially aroundthe energy transducer and configured to direct the energy toward thetarget tissue region. The housing has an energy transmission surfaceshaped to be applied adjacent to, or against, a surface of the eyelid.The energy transducer is disposed within the housing and oriented suchthat the energy is directed through the energy transmission surfacetowards the surface of the eyelid in a shaped pattern. The first safetysensor is operatively linked to the energy transducer and configured tomonitor the temperature of a portion of the eyelid. In some embodiments,the device is configured to heat the target tissue region sufficientlyto melt meibum within meibomian glands located within or adjacent to thetarget tissue region.

In some embodiments, the energy transducer may include at least one ofan LED, laser, incandescent lamp, xenon lamp, halogen lamp, luminescentlamp, high-intensity discharge lamp, and gas discharge lamp. In someembodiments, the energy transmission surface is substantiallytransparent to desired wavelengths and substantially blocks undesiredwavelengths.

In some embodiments, the waveguide includes a shaped reflective surface.The energy transducer and the waveguide may be configured to direct theenergy at the target tissue region while minimizing the amount of energypassing through the eyelid to the sclera, cornea, iris, pupil, vitreousbody, retina, and adjacent structures.

Some embodiments of the device further include an optical filter whichselectively removes undesired wavelengths; such undesired wavelengthsmay be within at least a portion of the ultraviolet, infrared, andvisible light spectra.

In some such embodiments, a second safety sensor is configured tomonitor proximity between the energy transmission surface and thesurface of the eyelid. In other such embodiments, the second safetysensor is configured to monitor whether the eyelids are open or closed.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned aspects, as well as other features, aspects, andadvantages of the present technology will now be described in connectionwith various embodiments, with reference to the accompanying drawings.The illustrated embodiments, however, are merely examples and are notintended to be limiting. Throughout the drawings, similar symbolstypically identify similar components, unless context dictatesotherwise. Note that the relative dimensions of the following figuresmay not be drawn to scale.

FIG. 1A is a cross-sectional diagram of a mammalian eye system 10.

FIG. 1B is a view of the underside surfaces of the upper and lowereyelids showing meibomian glands with healthy, clogged and atrophiedglands.

FIG. 2A is a schematic block diagram of one embodiment of an eyetreatment device according to some embodiments.

FIG. 2B is a schematic block diagram of another embodiment of an eyetreatment device.

FIG. 2C is a schematic block diagram of another embodiment of an eyetreatment device having a scleral shield.

FIG. 2D is a schematic block diagram of another embodiment of anophthalmic device having a scleral shield with imaging elements.

FIG. 2E is a close-up cross-sectional view of a portion of theembodiment of FIG. 2D.

FIG. 2F is a front view of the embodiment shown in FIG. 2E.

FIG. 2G is a schematic block diagram of another embodiment of anophthalmic device similar to FIG. 2D.

FIG. 2H is a schematic block diagram of another embodiment of anophthalmic device similar to FIG. 2C.

FIG. 3 is a schematic block diagram of an embodiment of an eyediagnostic and treatment device.

FIG. 3A is an enlarged view of one embodiment of a scleral shield shownin FIG. 3.

FIG. 4A is a schematic side plan view of one embodiment of an eyetreatment device.

FIG. 4B is a schematic front plan view of the energy transducer andwaveguide modules included in the eye treatment device embodiment ofFIG. 4A.

FIG. 4C is a schematic side plan view of the eye treatment deviceembodiment of FIG. 4A shown in use.

FIG. 4D is a schematic side plan view of another embodiment of an eyetreatment device.

FIG. 4E is a perspective view of the optical elements in anotherembodiment of an eye treatment device.

FIGS. 4F-H are front, side and cross-section views of the prism elementfrom FIG. 4E. FIGS. 4J-M are front, cross-section, side and perspectiveviews of the shaping lens element of FIG. 4E.

FIGS. 4N and 4P are theoretical graphical representations of theirradiance patterns produced by the optical elements of 4E.

FIG. 5A is a schematic side plan view of a further embodiment of an eyetreatment device.

FIG. 5B is a schematic front plan view of the eye treatment deviceembodiment of FIG. 5A.

FIGS. 5C-F are side, top, front and perspective views of portions ofanother device embodiment.

FIGS. 5G and 5H are theoretical graphical representations of theirradiance patterns produced by the optical elements of 5C-F.

FIG. 6 is a schematic side plan view of an embodiment of an eyetreatment system, which includes an eye treatment device and a scleralshield.

FIGS. 7A-7H are schematic front plan and side views of variousembodiments of a scleral shield.

FIG. 8 is a schematic side plan view of another embodiment of an eyetreatment device.

FIG. 9 is a schematic side plan view of another embodiment of an eyetreatment device including one or more cooling mechanisms.

FIG. 10 is a schematic side plan view of another embodiment of an eyetreatment device including one or more safety sensors.

FIG. 11A is a schematic side plan view of another embodiment of an eyetreatment device.

FIG. 11B is a schematic side plan view of another embodiment of an eyetreatment device.

FIG. 12 is a schematic side plan view of another embodiment of an eyetreatment device including vibrational means.

FIG. 13 is a schematic diagram of one embodiment of an eye treatmentsystem in use by an individual.

FIG. 14A is a schematic side plan view of an embodiment of an eyetreatment system.

FIG. 14B is a schematic front plan view of a portion of the eyetreatment system embodiment of FIG. 14A.

FIG. 15A is a schematic side view of an embodiment of an eye treatmentinstrument system.

FIG. 15B is a front sectional view taken along A-A of the embodimentshown in FIG. 15A.

FIG. 15C is a front view of the embodiment shown in FIG. 15A.

FIG. 15D is a side sectional view taken along B-B of the embodiment ofFIG. 15A.

FIGS. 16A-Q show unique configurations of the energy transmissionsurfaces, the scleral shields and support arms of the system, whichdefine an aperture that allows viewing of one or both eyelid marginsduring the application of heat and compression to the portion of theeyelid being treated.

FIGS. 17A-C show an embodiment of an energy transducer module incombination with an energy waveguide module and energy transmissionsurface.

FIG. 17D shows a graphical representation of the irradiance distributionof infrared light through an eyelid for the embodiment of FIGS. 17A-C.

FIGS. 17E-F depict an element of an energy transmission surface having acertain coating.

FIG. 17G is a graphical representation of the irradiance distribution ofinfrared light through an eyelid for an embodiment having a certaincoating on a portion of the energy transmission surface.

FIG. 17H shows the irradiance distribution of lime light on the outersurface of an eyelid for an embodiment having a certain coating on aportion of the energy transmission surface.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part of the present disclosure. Inthe drawings, similar symbols typically identify similar components,unless context dictates otherwise. The illustrative embodimentsdescribed in the detailed description, drawings, and claims are notmeant to be limiting. Other embodiments may be utilized, and otherchanges may be made, without departing from the spirit or scope of thesubject matter presented herein. It will be readily understood that theaspects of the present disclosure, as generally described herein, andillustrated in the Figures, can be arranged, substituted, combined, anddesigned in a wide variety of different configurations, all of which areexplicitly contemplated and form part of this disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.It will be understood by those within the art that if a specific numberof a claim element is intended, such intent will be explicitly recitedin the claim, and in the absence of such recitation, no such intent ispresent. For example, as used herein, the singular forms “a”, “an” and“the” are intended to include the plural forms as well, unless thecontext clearly indicates otherwise. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items. It will be further understood that the terms “comprises,”“comprising,” “have,” “having,” “includes,” and “including,” when usedin this specification, specify the presence of stated features,integers, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. Expressions such as “at least one of,” when preceding a list ofelements, modify the entire list of elements and do not modify theindividual elements of the list.

To assist in the description of the devices and methods describedherein, some relational and directional terms are used. “Connected” and“coupled,” and variations thereof, as used herein include directconnections, such as being contiguously formed with, or glued, orotherwise attached directly to, on, within, etc. another element, aswell as indirect connections where one or more elements are disposedbetween the connected elements. “Connected” and “coupled” may refer to apermanent or non-permanent (i.e., removable) connection.

“Secured” and variations thereof as used herein include methods by whichan element is directly secured to another element, such as being glued,screwed, or otherwise fastened directly to, on, within, etc. anotherelement, as well as indirect means of securing two elements togetherwhere one or more elements are disposed between the secured elements.

“Proximal” and “distal” are relational terms used herein to describeposition from the perspective of a medical professional treating apatient. For example, as compared to “distal,” the term “proximal”refers to a position that is located more closely to the medicalprofessional, while the distal end is located more closely to thepatient during treatment. For example, the distal ends of the devicesdisclosed herein oppose the proximal ends of the same devices, and thedistal end of a device often includes, for example, the end configuredfor placement against the eyelid of a patient.

“Transducer” is a term used herein to describe an element which receivesone form of energy and transforms it into another. For example, a lightsource may receive electrical energy and produce light energy. Likewise,an ultrasonic transducer may receive electrical energy and produceultrasonic energy.

“Light” as used herein refers not only to energy in the visible lightspectrum, but also to energy in the infrared and ultraviolet portions ofthe electromagnetic energy spectrum.

“Waveguide” as used herein refers to any means of influencing thepropagation, distribution or trajectory of electromagnetic energy suchas light, ultrasonic energy and radio frequency energy. As definedherein, an optical elements such as diffractors, refractors, diffusersand the like are included in this broad definition of a waveguide.

“Optical path length” is used herein to describe the length of the path(for example, within a tissue section) through which energy travels.

Embodiments disclosed herein relate to ophthalmic devices, systems, andmethods. The devices, systems, and methods disclosed herein can be usedto treat meibomian glands, ducts, orifices, and surrounding tissue andare particularly directed to the treatment of MGD, blepharitis andconditions having a physiological relationship with MGD and blepharitis,such as evaporative dry eye disease. FIG. 1A is a cross-sectionaldiagram of a mammalian eye system 10, which includes an eyeball 20 andsurrounding eyelid anatomy. As recited within this disclosure and asidentified in FIG. 1A, the “central ocular axis” 30 of the eye is thecentral axis running through the center of the cornea 22, iris 24, pupil25, lens 26, and vitreous body 28 of the eyeball 20. Eye system 10includes an upper eyelid 12, a lower eyelid 14, and eyelashes 16. Withinthe tissue of each eyelid 12, 14, there are meibomian glands 18 eachhaving a duct or orifice 19. In healthy eye systems 10, the meibomianglands 18 secrete out of ducts 19 a substance called meibum, comprisedprimarily of lipids and proteins. The meibum forms part of the tear filmthat covers the surface of the eyeball 20.

FIG. 1B is a view of the inner eyelid showing meibomian glands withhealthy, clogged and atrophied glands. Chronic blocking of the glands isassociated with MGD and some forms of blepharitis, and may lead tocapping of the ducts and/or atrophy of the glands. Inflammationassociated with MGD or blepharitis may in turn cause a furtherconstriction of gland ducts 19, leading to a reduction of meibomiangland secretion, and accordingly, a decreased amount of lipids in thetear film. Tear film with reduced lipid content may evaporate quicklyand lead to evaporative dry eye. A reduced tear film may also beassociated with increased levels of bacteria in and around the eye. Suchbacteria can aggravate the inflammation by themselves or by certainby-products which are irritating to the eye. It is believed that byperiodically clearing our chronically blocked glands, the glands can bespared from becoming permanently atrophied.

Another factor thought to contribute to blepharitis is the presence ofDemodex folliculorum and Demodex brevis mites, which are commonly foundon most humans, reported in higher quantities on individuals sufferingfrom blepharitis. The mites may live in the hair follicles of theeyelashes and eyebrows and in meibomian glands and sebaceous glands.Their presence alone may lead to inflammation in certain individuals,but it is also thought that such mites may harbor certain bacteria whichcan be released into the eyelid region during their lifecycle, leadingto further inflammation.

FIG. 2A is a schematic block diagram of an eye treatment device 100according to various embodiments. As shown in FIG. 2A, the depicteddevice 100 includes a power source module 110, an energy transducermodule 120, an energy waveguide module 130, and an energy transmissionsurface 140 (also referred to as a compression element). In someembodiments, the energy waveguide module 130 may be optional. In otherembodiments, the energy transducer module 120 and energy waveguidemodule 130 may be combined in a single unit.

The power source module 110 of various embodiments provides energy tothe energy transducer module 120. The power source module 110 mayinclude any structure configured for delivering power to one or moreother components of the eye treatment device 100. In some embodiments,the power source module 110 includes a disposable battery, arechargeable battery, a solar cell, a power transforming module such asa power supply or power converter, or a power transfer mechanism such asa cord, outlet, or plug configured to receive alternating current ordirect current from an external source.

The energy transducer module 120 may include one or more energytransducers configured to emit one or more forms or type of energy. Forexample, as described in more detail below, in some embodiments, theenergy transducers emit photonic, acoustic, radio frequency, electrical,magnetic, electromagnetic, vibrational, infrared or ultrasonic energy.In some embodiments, the transducer module 120 generates multiple typesof energy simultaneously or in a predetermined order.

The energy waveguide module 130 includes one or more structuresconfigured to control or focus the direction of energy emission from theenergy transducers. For example, the waveguide module 130 may includeone or more reflectors, refractors, diffractors, or diffusers (describedin more detail below) configured to focus photonic energy toward adesired region, or other structures for configuring and directing theenergy emission, such as ultrasonic horns or fiber optics.

The eye treatment device 100 of FIG. 2A may further advantageouslyinclude an energy transmission surface 140 configured to further directenergy generated by the energy transducer module 120 toward a desiredregion. For example, the energy transmission surface 140 may include oneor more lenses configured to focus energy generated by the transducermodule 120.

In some embodiments, the energy waveguide module 130 and the energytransmission surface 140 may also prevent or limit the transmission ofenergy generated by the energy transducer module 120 to particularregions of the eye. The energy transmission surface 140 may includeregions that are substantially opaque or non-transmissive to the energyproduced by the energy transducer module 120 and regions that aretranslucent or transmissive to the energy produced by the energytransducer module 120. The modules of the eye treatment device 100 aredescribed in further detail below in relation to other embodiments ofthe disclosure and may include other components.

FIG. 2B is a schematic block diagram of an eye treatment device 100according to various embodiments. FIG. 2B is similar to FIG. 2A andincludes a power source module 110, an energy transducer module 120, anoptional energy waveguide module 130, and an energy transmission surface140. The energy transmission surface 140 may be substantially solid, orit may include elements that are spaced apart from other parts of thesurface 140 or device 100. For example, surface 140 may include anextension element that is positioned at a certain distance from thesolid portion of surface 140. For example, in FIG. 2B, extension element143 is depicted as a mesh-like structure spaced apart from the mainportion of surface 140 (if any). Extension element 143 may comprise asurface that is at least partially transparent to the desired energygenerated by energy transducer module 120, while keeping a gap betweenthe main portion of the energy transmission surface 140 (if any) or theenergy waveguide (if any) or the energy transducer module and the eyelidsurface 12, 14. The gap created by extension element 143 may bebeneficial in providing a path for forced-air cooling of the eyelid, forexample. Additionally, pressing extension element 143 against the eyelidsurface may reduce the optical path length for heating the eyelid 12, 14and/or targeted components within the eyelid. Reducing the optical pathlength may be advantageous for heating tissue due to improvements inradiant throughput, decreased scattering, refractive index matching, andincreased fluence. Extension element 143 may be made of a low thermalmass material, like a thin-wire or plastic mesh or perforated thin metalor plastic surface, and may be structured to conform to the shape of theeyelid while applying pressure to the surface of the eyelid. In oneembodiment, extension element 143 may be structured so that when it ispressed against both the upper and lower eyelids, it can distribute theapplied pressure either uniformly or non-uniformly across the combinedupper and lower outer eyelid surfaces. For example, in one embodiment,extension element 143 may apply less pressure to the central ocular axis30 and more pressure elsewhere, which may be desirable in cases wherepressure applied repeatedly to the eyelids over the central ocular axismay be thought to increase the possibility of developing a complicationsuch as keratoconus. In other embodiment, extension element 143 may beactively heated or cooled.

FIG. 2C is a schematic block diagram of another embodiment of an eyetreatment device 100 having a power source module 110, an energytransducer module 120, an optional energy waveguide module 130, anenergy transmission surface 140 and scleral shield 300 (also referred toas a back plate). In this embodiment, one or more eyelids 12, 14 arepositioned between the energy transmission surface 140 and scleralshield 300.

The energy transducer module 120 may include one or more energytransducers configured to emit one or more forms or type of energy. Forexample, as described in more detail below, in some embodiments, theenergy transducers emit photonic, acoustic, radio frequency, electrical,magnetic, electromagnetic, vibrational, infrared or ultrasonic energy.In some embodiments, the transducer module 120 generates multiple typesof energy simultaneously or in a predetermined order. An optional energywaveguide module may be included to control or focus the direction ofenergy emission from the energy transducers, as described above.

The eye treatment device 100 of FIG. 2C may further advantageouslyinclude an energy transmission surface 140 configured to further directenergy generated by the energy transducer module 120 toward a desiredregion. The energy transmission surface 140 may include one or morelenses configured to focus energy generated by the transducer module120. The energy transmission surface 140 (and/or extension element 143shown in FIG. 2B) may be movable along a movement path 145 in order toadjust certain energy transmission properties (such as focus) and/or tocontact the surface of the eyelid 12, 14 and/or to apply pressure to theeyelid 12, 14. By applying pressure to the eyelid 12, 14 while keepingscleral shield 300 in a fixed spatial relationship relative to otherparts of device 100, the eyelid 12, 14 may be compressed, therebyreducing the optical path length for heating the eyelid 12, 14 and/ortargeted components within the eyelid. Reducing the optical path lengthis advantageous for heating tissue due to improvements in radiantthroughput, decreased scattering, refractive index matching, andincreased fluence. The eyelid may be compressed by the back platecompressing or pushing the eyelid against the compression element. Orthe eyelid may be compressed by the compression element compressing orpushing the eyelid against the back plate.

In some embodiments, the transducer module 120 may generate multipletypes of energy simultaneously, such as photonic, acoustic, radiofrequency, electrical, magnetic, electromagnetic, vibrational, infraredor ultrasonic energy. For example, a first energy may heat the outersurface of the eyelid while a second energy may penetrate more deeplyinto the eyelid tissue and/or interact with the scleral shield in modesdescribed in further detail below.

FIG. 2D is a schematic block diagram of another embodiment of anophthalmic device 100 having a power source module 110, an energytransducer module 120, an optional energy waveguide module 130, anenergy transmission surface 140 and scleral shield 300, similar to FIG.2C. In some embodiments, the scleral shield 300 may further include animage translator 155 integrated into scleral shield 300. FIG. 2E shows aclose-up cross-sectional view of image translator 155 embedded inscleral shield 300, with eyelid 14 positioned adjacent to imagetranslator 155. In the embodiment shown, image translator 155 isreflective. Illumination energy 170, which may be visible or infraredlight, for example, is passed through eyelid 14 and therefore throughmeibomian glands 18, and then along optical path 175 through energytransmissive material 185 as it reflects off of reflective surfaces 180,eventually exiting image translator 155 above the eyelid margin 14 a. Itwill be appreciated that the resulting image appearing out of imagetranslator 155 will be a shadow image, or transilluminated image, ofthat portion of eyelid 14 that is adjacent to image translator 155 andwhich is illuminated by illumination energy 170. In this manner, imagetranslator 155 allows viewing of a transilluminated image 190 of theinner side of the eyelid 14 under direct visualization or with the aidof a magnifying element or camera, shown collectively as a visualizationdevice or visualization means 160, without having to evert the eyelid.FIG. 2F is a front view of the same embodiment shown in FIG. 2E, showingtransilluminated images 190 of the meibomian glands.

Image translator 155 may comprise a set of mirrored surfaces or a prismhaving reflective surfaces. Alternatively, image translator may comprisea light-bending element such as a light pipe, a fiberoptic bundle, animage sensor, or some combination thereof. It will be appreciated thatvarious desirable optical properties may be incorporated into imagetranslator 155, such as image projection, angulation or magnification.Such properties may be achieved, for example, by curving the reflectivesurfaces 180, by shaping the surfaces of transmissive material 185and/or by varying the index of refraction, by varying the density anddistribution of fiber elements in a bundle, or by some combinationthereof. In embodiments where image translator 155 includes an imagesensor, such sensor may be of a CCD-type, CMOS type, luminescentconcentrator (such as has been fabricated at Johannes Kepler University,Linz, Austria), or any type of sensor that can capture thetransillumination data and translate it into either visual, optical orelectrical information.

In some embodiments, visualization of eyelid margin 14 a duringdiagnosis and treatment of eyelid 14 provides a significant benefit. Forexample, as described above, positioning eyelid 14 between the energytransmission surface 140 and scleral shield 300 having image translator155 allows visualization of the transilluminated image of the eyelid andmeibomian glands. As shown in FIG. 1B, the morphology of healthy,clogged and atrophied glands is distinct enough to allow diagnosis ofthe status of each gland by viewing a transilluminated image of theglands. Referring back to FIG. 2D, gland status may be also be evaluatedwithout transillumination by observing eyelid margin 14 a while movingenergy transmission surface 140 along movement path 145 to press againsteyelid 14. As the eyelid 14 is compressed, eyelid margin 14 a isobserved and gland status is assessed by the quality and quantity ofsecretions from ducts 19, as discussed previously.

If treatment is desired after diagnosis, device 100 may be repositionedalong eyelid 14 so that the preponderance of diseased glands arepositioned between energy transmission surface 140 and scleral shield300. Once ideally positioned, energy transmission surface 140 may bemoved along movement path 145 to contact the surface of the eyelid 12,14 and/or to continue to move toward the scleral shield 300 and applypressure to the eyelid 12, 14.

Referring again to FIG. 2D, an optional coupling medium 195 may bepositioned between the eyelid 12, 14 and the energy transmission surface140. Coupling medium 195 may be a fluid, gel, cream or the like, and maycontain an agent such as glycerol, which can increase the efficiency oflight transmission into the eyelid and target tissue by reducing lightscattering and increasing light transmittance by reducing the refractivemismatch between the eyelid 12, 14 and the energy transmission surface140. It may also assist in reducing scattering by hydrating portions ofthe eyelid skin surface such as the stratum corneum.

FIG. 2G is a schematic block diagram of another embodiment of an eyetreatment device 100 having a power source module 110, an energytransducer module 120, an optional energy waveguide module 130, anenergy transmission surface 140, and image translator 155 integratedinto scleral shield 300. The image translator 155 allows at least aportion of the energy from the energy transmission surface 140 to beredirected toward the inner side of the eyelid 14. For example, theeyelid 14 may be positioned between the energy transmission surface 140and scleral shield 300 which includes the image translator 155. Theenergy transmission surface 140 directs energy toward at least one ofthe outer side of the eyelid and the image translator 155. The imagetranslator 155 is able to redirect energy from the energy transmissionsurface 140 toward the inner side of the eyelid. The benefit ofdirecting energy via the image translator 155 to the inner surface ofthe eyelid is that it can provide an efficient mode of deliveringenergy, and thus heat, to at least the portion of the inner surfaceadjacent to the eyelid margin. By combining this mode of heating (viaimage translator 155) with the mode of heating whereby the energy isdirected through the eyelid, overall heating efficiency of the innereyelid surface may be optimized, and preferential additional heating ofthe inner surface adjacent to the lid margin may be achieved, since thatis the zone where significant clogging and blockage may occur. Anadditional temperature sensor may be positioned near the inner eyelidsurface tissue adjacent to the lid margin, where the preferentialadditional heating may occur (described and depicted below withreference to FIG. 3).

FIG. 2H is a schematic block diagram of another embodiment of an eyetreatment device 100 having a power source module 110, an energytransducer module 120, an optional energy waveguide module 130, anenergy transmission surface 140 and scleral shield 300, similar to FIG.2C. In some embodiments, the scleral shield 300 may further include anenergy conversion coating 194 capable of being activated by certaintypes of energy passing through the eyelid. In one embodiment, theenergy conversion coating 194 is able to convert the direction of energyback toward the inner side of the eyelid, using the same form of energythat originally passed through the eyelid. In another embodiment, theenergy conversion coating 194 may alter the type of energy and direct oremit the altered energy in a preferred direction. In one embodiment, thecoating is a phosphorescent. By way of example, the energy transmittedthrough the eyelid may be visible or infrared light of a wavelength thatpasses readily through the tissue with little absorption, and once thatenergy reaches energy conversion coating 194, the phosphorescentmaterial emits light energy of a different wavelength that is morereadily absorbed by the tissue adjacent to the coating, which, in thepreferred embodiment, would be the inner surface of the eyelid,containing the meibomian glands. In another embodiment, a certain formof energy absorbed by the coating triggers an exothermic chemicalreaction that may heat the inner surface of the eyelid. Some embodimentsof FIGS. 2A-2H may also include one or more of the following: a scleralshield with support arms, a reflective imager integrated into scleralshield, a display of various temperatures, a consumable portion, aconnector and circuitry for communication between device and theconsumable in order to identify the consumable and prevent reuse, a datalogger, a voice recorder and a camera with recording and/or transmissioncapability activated by certain types of energy passing through theeyelid. In one embodiment, the energy conversion coating 194 is able toconvert the direction of energy back toward the inner side of theeyelid, using the same form of energy that originally passed through theeyelid. In another embodiment, the energy conversion coating 194 mayalter the type of energy and direct or emit the altered energy in apreferred direction. In one embodiment, the coating is a phosphorescentmaterial that is activated by the energy transmitting through the eyelidfrom the energy transmission surface 140. By way of example, the energytransmitted through the eyelid may be visible or infrared light of awavelength that passes readily through the tissue with littleabsorption, and once that energy reaches energy conversion coating 194,the phosphorescent material emits light energy of a different wavelengththat is more readily absorbed by the tissue adjacent to the coating,which, in the preferred embodiment, would be the inner surface of theeyelid, containing the meibomian glands. In another embodiment, acertain form of energy absorbed by the coating triggers an exothermicchemical reaction that may heat the inner surface of the eyelid.

FIG. 3 is a schematic side plan view of one embodiment of an eyetreatment device 200. The eye treatment device 200 shown in FIG. 3 isshown to be positioned relative to an eyeball 20 for treatment of theeyelid 14 for MGD, blepharitis and other medical conditions. In someembodiments, the eye treatment device 200 is configured to heat theinner and/or outer surfaces of the eyelid while compressing the eyelid.As the heat from the eye treatment device 200 is transmitted to the eyesystem 10, particularly to the treatment tissue such as the meibomianglands, the heat can soften the meibum and thereby allow the meibum tobe more readily expressed during massage or eye exercises. The eyetreatment device 200 can include configurations of the modules depictedin FIGS. 2A-2H, along with additional components useful in operation ofthe eye treatment device 200.

The eye treatment device 200 can include a housing 202 coupled with aremovable or consumable portion 260, which may be coupled to housing 202u engagement means 186, which can be pins, alignment guides, slidelocks, and the like. Housing 202 may include a power source module 110,an optional controller 212, an energy transducer module 120, and anenergy transmission surface 140 in a slidable relationship alongmovement path 145 with energy transducer module 120. Alternatively,energy transmission surface 140 may linked with, or part of, energytransducer module 120, and optionally thermal management structure 220,and together they may be in a slidable relationship with respect tohousing 202 or other parts of device 200. Movement of energytransmission surface 140 and linked parts may be done using actuator182, for example. The energy transducer module 120 of some embodiments,such as is shown in FIG. 3, may include an LED device formed of one ormore of an LED emitter 207, an LED lens 208, a thermal managementstructure 220, and an energy transducer module driver 209. The housing202 may further include visualization means 160 for enhanced monitoringof the eyelid margin during diagnosis and treatment, a display ordashboard 218 showing various temperatures of the eyelid, such as innerand/or outer surface temperatures, a datalogger 214, voice recorder 213,and circuitry 226 a for communication between device and consumablecircuitry 226 b in order to identify the type of consumable, ensure thatthe consumable is in proper alignment and/or prevent reuse of theconsumable. The consumable portion 260 may include a scleral shield 300that can be positioned between the eyelid 12, 14 and eyeball 20 to coversensitive anatomy of the eye system 10 (such shown in FIG. 1). Forexample, the scleral shield may be positioned over the sclera 21 andcornea 22 and may also provide protection to other internal anatomy ofthe eye such as the iris 24, pupil 25, lens 26, and other lightsensitive anatomy of the eye system 10. Use of the scleral shield 300can increase safety and reduce the potential of harmful light emissionsfrom the energy transducer module 120 reaching and damaging sensitiveeye anatomy. The scleral shield 300 may be formed from an energyabsorbing material and/or may have an energy absorbing front face 302.In either case, energy transmitted through the eyelid which is absorbedby the scleral shield 300 or front surface 302 may heat the shield orfront surface, respectively, and thereby provide warmth to the innersurface of the eyelid. The back surface and edges of scleral shield 300are preferably made from a material and process that ensures a smooth,burr-free finish that cannot cause injury, or reduces the likelihood ofinjury, to the cornea or other sensitive eye structures. In onepreferred embodiment, the back surface and edges are covered with anexpanded Teflon(r) (ePTFE) material. The scleral shield 300 may alsoincorporate one or more temperature sensors 310 in order to monitortemperature, as well as force or pressure sensors 221 to monitor theamount of force or pressure applied on the eyelid. Electrical conductorssuch as wires 420 may connect sensors 310 and 221 to circuitry in thehousing 202. FIG. 3A shows one embodiment of a scleral shield 300further including an image translator 155 which, as describedpreviously, enables viewing of the inner side of the eyelid 14 and themeibomian glands behind the eyelid. In some embodiments, the scleralshield 300 may further include a data transmission means and/or anembedded power source, both discussed in more detail below as datatransmission means 320 and embedded power source 330, such as in FIG.7A. By way of further clarification, scleral shield 300 may be coupledto housing 202 in various manners such as with one or more wires 420,such wires having insulation with sufficient mechanical strength toserve as support arms 262. In addition, some embodiments may havecircuitry 226 a and 226 b for communication between the device and theconsumable.

In some embodiments, a lens 208 may be used, such as an LED lens overthe LED emitter 207. In some embodiments, the lens 208 may be aspecially shaped lens used to control the direction and intensity of theLED emitter 207 to the desired treatment tissue and/or the scleralshield 300. In some embodiments, the energy transmission surface 140 mayact as a lens or used in combination with a lens, to focus and directthe energy from the energy transducer module 120 or LED emitter 207 tothe desired treatment areas.

Each of these components, either alone, or in combination with othercomponents any of the embodiments described herein.

The eye treatment device 200 can include a power source module 110 forproviding power to the various components of the eye treatment device200 and may be electrically coupled to some or all of the components. Insome embodiments, the power source module 110 is battery operated usingeither regular or rechargeable batteries that may be coupled to arecharging system. In other embodiments, the power source module 110 maybe coupled to an external power source, such as an electrical outlet orexternal battery supply. In some embodiments, the power source module110 may be electrically coupled with the controller 212 to receiveinstructions from the controller 212 to provide electrical energy to thevarious components of the eye treatment device 200.

In certain embodiments having a controller 212, the controller 212 canreceive input instructions from a user (for example, through a userinterface device 270, such as a button, switch, touch screen, voicecommands, from another module or device, such as a smartphone) to emitlight from the LED emitter 207. Upon receipt of the user inputinstructions, the controller 212 can instruct the power source module110 to deliver energy to or from the energy transducer module driver 209which enables LED emitter 207 to convert the electrical energy from thepower source module 110 into another form of electromagnetic energy(such as light). In this manner, the energy transducer module driver 209and the LED emitter 207 can act as a transducer of the electrical energyreceived from the power source module 110.

The energy transducer module driver 209 can comprise any LED-poweringand controlling circuitry, whether configured as an actual printedcircuit board, an integrated circuit, or discrete components. In someembodiments, it serves the function of an LED driver, providing acontrolled current, voltage or power level through the LED emitters 207within the LED specifications to provide a desired illuminationintensity therefrom. Optionally, the LED printed circuit board caninclude a pulse-width modulation function, PID circuit, or similarscheme in order to modulate the effective intensity of the emissionsover time to achieve a desired heating of a target region of the eyelid.

The LED emitter 207 is a part of one type of energy transducer module120 that can be configured to emit light of the appropriate wavelengthnecessary for the desired treatment. The treatments may include one ormore of the following: diagnosing the eyelids 12, 14 by the illuminatingthe inner and/or outer surfaces, eyelid margins, and/or the meibomianglands behind the eyelids; heating the target tissue region of the eyesystem 10 (e.g., the meibomian gland behind the eyelids 12, 14); andantibacterial treatment to kill bacteria in the eye system 10. Note thatthe descriptions of the various devices herein (including the eyetreatment device 200) are exemplary, and not limiting. Thus, forexample, while this detailed description mentions particular elementsand circuitry having particular functions, this does not limit thedisclosure to those particular embodiments. For example, while LEDs arementioned, other light sources, such as incandescent, xenon, halogen,high-intensity discharge, cold cathode tube, fluorescent, laser andother light sources or energy sources can be used. Similarly, while acontroller 212 and energy transducer module driver 209 are mentioned, itwill be understood that the controller could be integrated with drivercircuitry for the light source or circuitry for a solid-state or otherpower supply, or other configurations could be used to provide thedesired result. Further, some or all of the functions described as beinghandled by, or controlled by, controller 212, may be implemented usingdiscrete logic or analog circuitry, or a combination thereof. Moreover,although the various embodiments such as device 200 are illustratedschematically, they can be produced in a variety of handheld orstationary configurations with optional gripping surfaces, manipulationand control structures, and the like. Furthermore, the devices describedherein can be designed for use in a plurality of settings, includingin-home use and use within an eye care professional's office, a healthclinic, or other healthcare facility.

In some embodiments, the energy transducer module 120 can instead be,for example, a broad spectrum lamp, such as an incandescent, xenon, orhalogen lamp. Such broad spectrum lamps can be used in conjunction withone or more color filters to remove specific wavelengths not necessaryfor the treatment of the eye condition, or to remove specificwavelengths that may be harmful to the treatment tissue in the targetregion (e.g., meibomian glands 18) of the eye system 10 duringapplication of energy from the energy transducer module 120 to thetreatment tissue.

In some embodiments, the energy emitted from the power source module 110can be converted into visible light and can be emitted by the LEDemitter 207. For some embodiments, it is desirable to use light with awavelength selected to: a) penetrate the eyelid to the depth of themeibomian gland (e.g., typically about 1-2 mm in certain individuals) orother adjacent target tissue in the eyelid, and be absorbed there, b)minimize the amount of light that penetrates beyond the eyelid tissue,and c) minimize the amount of heating that occurs at the surface of theeyelid. For example, in some embodiments, the LED emitter 207 can emitlight having a wavelength in the range of about 400-700 nm. In someembodiments, the LED emitter 207 can emit light that is substantially asingle color selected for optimal treatment of the meibomian glands 18in the eye system 10. In some embodiments, the LED emitter 207 can emitlight in a range of wavelengths, the wavelength being selectable basedon the treatment requirements of the patient, or based on the intendedpurpose of the particular step in a multi-step treatment regimen.

In some embodiments, an illumination source emitting wavelengths in therange of 500-600 nm is chosen. In selecting wavelengths in the range of500-600 nm, a plurality of considerations may be taken into account. Forexample, this range may be selected to achieve the highest absorption oflight rays in tissue. Light energy incident on mammalian skin isreflected, transmitted, or absorbed. Reflection is a function of skinproperties, wavelength, and angle of incidence. Light rays that reachthe skin surface orthogonal to the plane of the surface are reflectedless than those that reach the skin at an oblique angle. Transmission oflight through the skin is a function of internal scattering, wavelength,and absorption. Internal scattering is a function of the chemical andphysical properties of the skin and underlying tissues. Eyelidthickness, density of keratinocytes, collagen, and fat may play a role.Absorption is primarily a function of the concentration and distributionof certain molecules called chromophores which tend to selectivelyabsorb certain wavelengths of light. In human skin, the primarychromophores that absorb light in the visible spectrum areoxyhemoglobin, deoxyhemoglobin, various melanins, and to some extent,water. Water does not significantly absorb wavelengths of light untilthe deep red and infrared part of the spectrum. Melanins tend to have afairly high degree of absorption of the visible spectrum, tapering offgradually as wavelength increases. Two absorption peaks foroxyhemoglobin are seen at around 532 nm and 577 nm. Deoxyhemoglobinpeaks around 550 nm.

In various embodiments, engineering constraints also affect wavelengthselection. The wavelength selected is one that can be emitted by adevice, which can be readily produced in a practical configuration, witha wattage and physical package appropriate for a device that deliverslight energy to the eyelid. In the case of very high power LEDs, thereare presently limited choices, although future improvements are likely.For example, LED Engin Inc. (San Jose, Calif.) produces green LEDs in a10 W version, such as LZ4-00G108, having a nominal center/peakwavelength of around 523 nm. Limited quantities are also available withpeak wavelengths of about 527 and 532 nm.

Various embodiments emit wavelengths within the 500-700 nm portion ofthe visible spectrum in order to produce the desired tissue heatingeffect without excessive transmission through the eyelid (and subsequentunwanted heating of structures beyond the eyelid), and without excessivesurface heating. Furthermore, emitting wavelengths within this portionof the visible light spectrum avoids the undesired portion of theelectromagnetic spectrum for embodiments that do not incorporate ascleral shield, including ultraviolet, infrared, and blue.

In some embodiments, longer wavelengths of light are used penetratedeeper into the tissue. For example, ‘red’ and near-infrared (NIR) atwavelengths between 700-1000 nm pass more readily through the eyelid,penetrating more deeply than the wavelength ranges described above.There is an “optical window” of human tissue around 800-900 nm, whereenergy passes most efficiently through tissue and eyelids due to thefact that chromophore absorption is at its lowest level. For theapplication of light therapy to the eyelids without the use of a scleralshield, the use of NIR would likely not be used due to excessive lightenergy passing through the eyelid directly to the eye, possiblyaffecting sensitive tissues of the eye. When using the scleral shield toprotect the eye, however, NIR may be used advantageously to pass throughthe eyelid. For example, NIR at 850 nm may pass through the eyelid andbe absorbed by the scleral shield, which, in turn, can warm adjacenttissue on the inner surface of the eyelid. For completeness ofdiscussion, it should be noted that certain wavelengths ofshort-wavelength and mid-wavelength infrared (sometimes referred to asIR-B and IR-C) have higher levels of absorption by water than thehighest combined absorption of the other chromophores discussed above.In particular, a wavelength of 3,000 nm has been shown to have suchhigher absorption. As such, there may be embodiments that use thiswavelength or others within the band safely, with or without a scleralshield. Note that there are also other “optical windows” (in addition tothe window mentioned at 800-900 nm) at these higher wavelengths, whichmay be advantageous to utilize in some embodiments.

In some embodiments, an illumination source emitting blue or violetlight in the range of 400-450 nm may be used to reduce and/or eliminatebacteria in the eye system 10. It is known that exposure to visiblelight, more specifically, blue or violet light wavelengths, causesinactivation of certain bacterial species. Common bacteria include S.aureus, S. epidermidis, B. oleronius, and P. acnes. In selectingwavelengths in the range of 400-450 nm, a plurality of considerationsmay be taken into account. For example, it is important that theemitting source (LED) does not emit a significant amount of energy belowabout 400 nm, which is in the UVA spectrum and can be associated withskin cancer.

In another embodiment, one or more wavelengths of light may be chosenwhich are preferentially absorbed by the exoskeletons, internalstructures or eggs of the Demodex mites, in order to kill, inactivate orinterrupt reproductive processes.

In some embodiments, an illumination source may be used to characterizethe tear film thickness and stability. For example, the energytransducer module could have a cobalt blue source, and the visualizationmeans 160 (viewing lens, for example) could have a yellow Wrattanfilter, and the patient could be given fluorescein eye drops, wherebythe clinician could measure the tear break-up time by viewing thesurface of the eye through the Wrattan filter. Alternatively, variouswavelengths of photonic energy could be shined onto or across thesurface of the eye, with or without indicator eye drops, and eitherthrough direct visual observation or image capture and processing, thestability and/or thickness of the tear film and/or lipid layer may bedetermined.

In another embodiment utilizing LEDs as an illumination source, the LEDemitter 207 can include one or more multi-spectral LEDs or multiple LEDsto emit light of differing or the same wavelength from each LED. In someembodiments, each LED of the LED emitter 207 is configured to emit lightof a different wavelength. The LED emitter 207 can emit the light fromeach differently colored LED either consecutively or simultaneously. Forexample, in some embodiments, the LED emitter 207 can include a red,green, blue (RGB) LED system, or other multi-spectral LED system, toemit light of various wavelengths in the visible light spectrum and IRspectrum. In some embodiments, the LEDs of the LED emitter 207 can beconfigured to operate simultaneously to emit white light. Alternatively,in some embodiments, the user can select the wavelength of light to beemitted from the multi-spectral LEDs. Further, an LED with using aspecial phosphorescent coating may be fabricated in order to produce themost efficient output spectrum relative to input power.

In some embodiments, the LED emitter 207 can include a high-intensityLED array. The high-intensity LED array, as part of the LED emitter 207,can, in some embodiments, operate at an input power rating of about0.5-75 W, but preferably in a range of 1-10 W. To help keep thetemperature of energy transducer module 120 within functional limits,thermal management structure 220 (such as a heat sink other substantialthermal mass) may be thermally linked to LED emitter 207. In a specificembodiment, the high-intensity LED array may emit light having awavelength of between about 500-600 nm.

The energy transducer module 120 can, in some embodiments, provideelectromagnetic energy to the treatment tissue in the form of infraredenergy, such as in the NIR band described above. For example, the LEDemitter 207 can be a commercially available LED such as LZ4-00R408,which emits 850 nm NIR and is manufactured by LED Engin, Inc. (SanJose). Additionally, the energy transducer module 120 can be anothersource of infrared energy instead of an LED light source, such as, forexample, an incandescent, xenon, halogen, cold incandescent, or halogenbroad spectrum lamp configured to emit infrared energy to the treatmenttissue site.

The eye treatment device 200 may include a reflector (such as reflector210 in other embodiments below), which may act as a waveguide to directthe electromagnetic energy (e.g., light) emitted from the energytransducer module 120. The reflector can be configured to directelectromagnetic energy evenly from the point source, such as, forexample, the LED emitter 207, through the energy transmission surface140, to the target treatment site of the patient.

The energy transducer module 120 can include a lens 208 that can be usedin conjunction with the LED emitter 207 or other electromagnetic energysource to direct the energy to the eyelid at a desired angle or in adesired pattern, at a desired intensity.

Shown in FIG. 3 is an energy transmission surface 140 forming part ofthe eye treatment device 200. The energy transmission surface 140 has aslidable relationship along movement path 145 relative to the energytransducer module 120. The energy transmission surface 140 can bepositioned in the housing 202 at a location distal to the energytransducer module 120, and positioned in between the energy transducermodule 120 and the tissue treatment site of the eye system 10.Positioned in this manner, the energy transmission surface 140 can pass,or receive and transmit, the electromagnetic energy transmitted from theenergy transducer module 120. In some embodiments, the energytransmission surface can be a concave shape (relative to the eyetreatment device 200), such that the energy transmission surface 140corresponds to the shape of the eyelids 12, 14 when closed. The energytransmission surface 140 may be shaped such that any electromagneticenergy emanating from the energy transducer module 120 must pass throughthe energy transmission surface 140.

In some embodiments, the energy transmission surface 140 is positionedadjacent to the eyelids 12, 14, and does not physically contact theeyelids 12, 14, but instead transfers heat to the treatment tissueradiantly. The energy transmission surface 140 can be substantiallytransparent to the desired electromagnetic energy transmitted by theenergy transducer module 120 to allow for the transmission of energyfrom the energy transducer module 120 without significantly hinderingthe desired energy type or wavelength from reaching the treatmenttissue. In some embodiments, the energy transmission surface 140 can bemade of an optical plastic, sapphire, glass, calcium fluoride, orfiberglass. It can have an easy to clean outside surface and can bescratch resistant. Optionally, a temperature sensor 310 may bepositioned on, in or adjacent to energy transmission surface 140 toprovide temperature feedback for the surface 140 and/or the outersurface of the eyelid.

In some embodiments, the energy transmission surface 140 can beconfigured to operate in conjunction with the energy transducer module120 to filter unwanted wavelengths from reaching the treatment tissue orother portions of the eye system 10. For example, in some embodiments,the illumination source may transmit electromagnetic energy in both theIR and visible light spectra. The energy transmission surface 140 can beused to allow passage of, for example, the energy from the visible lightspectrum, but filter out the energy from the IR spectrum. Likewise, ifit is desired that only energy from one color reaches the treatmenttissue, the energy transmission surface 140 can be used as a bandpassfilter or be used with a filter to restrict passage of energy ofwavelengths other than the color desired.

In some embodiments, the energy transmission surface 140 can beconfigured to come in physical contact with the eyelids 12, 14. Asdiscussed above, in some embodiments the energy transmission surface 140may be in a slidable relationship along movement path 145 with theenergy transducer module 120. This allows the energy transducer module120 to be in a fixed relationship with the eyelid while the energytransmission surface 140 may be moved forward into contact with theeyelids 12, 14. Alternative approaches to reducing the space between theouter surface of the eyelids 12, 14 and the energy transmission surface140 are possible. For example, the energy transducer module 120 andenergy transmission surface 140 may move together toward the eyelids,with the scleral shield 300 remaining in a relatively fixed position, orthe scleral shield 300 may move relative to the other parts of thedevice. In any case, movement is preferably done manually by theclinician in order to allow the clinician some measure of tactilefeedback. In certain embodiments, the eye treatment device 200 mayinclude an actuator 182 such as a lever, button, wheel, slider or switchto move the energy transmission surface 140.

In some embodiments, at least a portion of energy transmission surface140 may be configured as a single-use cover element 147, as shown inFIG. 3. Preferably, such single-use cover element 147 is incorporatedinto the consumable portion 260 of the device, wherein the single-usecover element 147 is automatically aligned and loaded onto energytransmission surface 140 as the consumable portion is attached to thehousing 202.

In some embodiments, the energy transmission surface 140 may be heatedto conductively transfer heat to the treatment tissue. In otherembodiments, most of the tissue heating occurs as a result of radiantheating from the energy transducer module 120 to the tissue and/or thescleral shield 300, wherein substantially all of the desiredelectromagnetic energy passes through energy transmission surface 140,with little or no heating of the energy transmission surface 140. Instill other embodiments, tissue heating may be done as a result of acombination of conductive heating caused by pre-heating or activeheating of energy transmission surface 140 and radiant heating of tissueand/or the scleral shield. The energy transmission surface 140 mayincorporate an energy-absorbing layer or pattern that may be pre-heatedby light energy or other means, for example up to 42 degrees Celsius,prior to contact with the outer surface of the eyelid. Or, energytransmission surface may be made from a thermally-conductive materialand may be heated by a heater that is thermally linked to energytransmission surface 140. In the case where surface 140 is made from athermally-conductive material, the material may be transmissive to anenergy source (such as light) coming from energy transducer module 120,or it may be solid, opaque or otherwise not transmissive to another formof energy other than conductive heating. In the case where surface 140is opaque or non-transmissive, it may be made from a conductive metalsuch as copper or aluminum, in which case surface 140 may be heated byan energy transducer module 120 comprising any means of heating athermal mass (such as a resistive heater), and then pushed against theeyelid to conductively heat the eyelids. In the case where surface 140is transmissive to another form of energy as well as thermallyconductive, it may be fabricated from materials such as sapphire,calcium fluoride, diamond, graphene and the like. In one preferredembodiment, up to three modes of heating may occur simultaneously: i)the inner surface of the eyelid is warmed using red or infrared lighttransmitted to an energy-absorbing scleral shield 300, ii) eyelid tissueis heated radiantly by visible light (e.g., green) which is absorbed bychromophores, and iii) eyelid tissue is heated conductively by bringinga pre-heated energy transmission surface 140 into contact with the outersurface of the eyelid. It will be appreciated that a significantadvantage of using the light-based heating techniques described herein,and specifically infrared heating of an energy-absorbing surface, aloneor in combination with the other two modes of heating (visible lightheating of chromophores and conductive heating of the tissue), heatingof the target tissue may be accomplished significantly faster than withany conventional method of conductive heating of the outer or innereyelid surfaces. Specifically, with these combined modes, the meibomiangland tissue may be brought up to a temperature of, for example, about40-42 degrees Celsius, in less than one minute. Specifically, in somecases, the meibomian gland tissue may be brought to about 40-42 degreesCelsius within 10, 15, 20, 25, 30 or 45 seconds.

As shown in FIG. 3, a visualization device or means 160 may be used toview the eye system 10. In some embodiments, the visualization means 160may be part of eye treatment device 200. In other embodiments, thevisualization means 160 may be a separate component. The visualizationmeans 160 may include, for example, a magnifier, a camera, microscope, aslit lamp instrument, or other suitable visualization instrument.

In some embodiments, the scleral shield 300 may further include an imagetranslator 155 that allows viewing of a transilluminated image of aportion of the eyelid and the meibomian glands. As described previously,the image translator may include, for example, one or more reflectivesurfaces, mirrors, light pipes, prisms, fiber bundles, image sensors orother suitable image translation means. As shown in FIG. 3, the imagetranslator 155 is integrated into scleral shield 300, but in otherembodiments, the image translator 155 may be a separate component 2

In some embodiments, an additional shielding element 258 may be used toprevent unwanted photonic energy (such as IR or blue/violet light) fromreflecting off the transillumination element back to the clinician. Forexample, the shielding element 258 may be a thin, opaque shield orfilter (blocking at least visible blue and IR light energy) that swings,flips, or slides (as indicated in FIG. 3) into position over the imagetranslator 155 and possibly also the energy transducer module 120 orenergy transmission surface 140 during the heating and blue/violet lighttreatment modes, to protect the clinician. Alternatively, a portion ofimage translator 155 and/or visualization means may include a selectiveoptical filter or photochromic element, such that during low-levelillumination of the eyelid for purposes of evaluating transilluminatedimages of the meibomian glands, the photochromic element passessubstantially all of the light, whereas during the heating mode whereinfrared energy or high-level visible light may be used, some or all ofthat energy may be attenuated, thereby shielding the clinician fromharm.

By way of further clarification, several classes of embodiments will nowbe described. In one class of embodiments, devices are intended forself-administered use by individuals, typically in a home-useenvironment. For this class, scleral shields are not practical to use,and therefore, there is a higher risk of unwanted forms of energy (suchas certain wavelengths of light or infrared energy) penetrating theeyelids and reaching sensitive anatomy of the eye. As such, this classof embodiments are preferably limited to the use of safer forms ofenergy such as visible light in the range of 450-700 nm. In anotherclass of embodiments, devices are intended for use by eye careprofessionals in a controlled office environment, where a treatmentsystem having a scleral shield component can be safely utilized. In thisclass, the scleral shield can be designed with shapes and materials toensure that little or no damaging energy reaches sensitive eyestructures.

IN-OFFICE DEVICE—Embodiments of the in-office device may include one ormore of the following: diagnosing the meibomian glands; treating themeibomian glands; and antimicrobial treatment of the eye system. In oneset of preferred embodiments, diagnosing the meibomian glands is carriedout two ways. First, using visible or IR illumination from the energytransducer module which is directed toward the outer surface of theeyelid in order to view and evaluate the meibomian glands using theimage translator, with or without the visualization means. Second, byslight compression of the eyelid while observing the eyelid margins tonote the quantity and quality of oily secretions from the meibomiangland ducts. For treatment, in one set of embodiments, the eyelid isheated and compressed. Near infrared (NIR) energy from the energytransducer module at approximately around 800-900 nm is transmittedthrough the eyelid to the scleral shield, which then heats up andconsequently warms the inner surface of the eyelid. Additionally,visible light from the energy transducer module in the range of about500-600 nm (green light) is directed at the outer surface of the eyelidwhich heats the tissue by means of chromophore absorption. The energytransmission surface is then moved toward the eyelid by the clinicianvia direct or indirect manual control, in order to compress the eyelidbetween the energy transmission surface and scleral shield. Optionally,the energy transmission surface may be pre-warmed and/or actively warmedduring the treatment to provide some conductive heating of the outereyelid. The temperature of the inner and/or outer eyelid surface may bemeasured and displayed for the clinician. The clinician applies heatingenergy and compressive force while visually monitoring the eyelid marginto optimize the expression of meibum from clogged meibomian glands.Finally, the energy transducer module may produce blue/violet light inthe range of about 400-450 nm to reduce and/or eliminate bacteria in theeye system 10.

HOME-USE DEVICE—Embodiments of the in-home device use visible lighttransmitted through the energy transmission surface from the energytransducer module aimed at the outer surface of the eyelid to heat thetissue by means of chromophore absorption. In certain preferredembodiments, the visible light may be high-intensity broad spectrum(e.g., white) LED light passing through certain filters, or it may be agreen, greenish-yellow, or greenish-white LED (500-600 nm) with nofilters. In some embodiments, the energy transmission surface istransparent to visible light and is thermally conductive, allowingwarming (e.g. to 42 degrees Celsius) prior to or during compression ofthe surface against the eyelid (see FIG. 2A). In some embodiments, theenergy transmission surface may have an extension element 143 (such asin FIG. 2B and described previously) that allows most of the lightenergy to pass through it, while keeping a gap between the energytransducer module and the eyelid surface 12, 14 (to enable passive oractive air cooling of the eyelid, for example). The energy transmissionsurface may conform to the shape of the eyelid and apply pressure to thesurface of the eyelid to shorten the optical path length of radiantenergy. In some embodiments eyecups are utilized to prevent light fromescaping from the immediate treatment area and to keep at least aportion of the device at a predetermined distance from the eyelids orperiocular region.

FIGS. 4A-4C are representative of another embodiment of an eye treatmentdevice. FIG. 4A is a schematic side plan view of an eye treatment device200. The eye treatment device 200 shown in FIG. 4A is positionedadjacent to an eyeball 20 for treatment of the eyeball for MGD,blepharitis and other medical conditions. For simplicity, sensitive eyestructures such as the cornea, iris, pupil lens, and adjacent elementsare depicted in FIGS. 4A-D, 5A-B, 6, 11A-B, 12, 13 and 15A as a singleelement called anterior eye structures 27. The eye treatment device 200can include configurations of the modules depicted in FIGS. 2 and 3,along with additional components useful in operation of the eyetreatment device 200. The eye treatment device 200 can include a powersource module 110, a controller 212, an energy transducer module 120, anenergy waveguide in the form of reflector 210, and an energytransmission surface 140. The energy transducer module 120 of someembodiments may include an LED device formed of one or more of an LEDemitter 207, an LED lens 208, and an energy transducer module driver209. Each of these components, either alone, or in combination withother components (either shown herein or not disclosed) can correspondor be part of the modules described in relation to FIGS. 2A-2H. Thecomponents of the eye treatment device 200 can be contained in a housing202. Some of the embodiments of the treatment device 200 may alsoinclude a consumable portion 260 and/or a scleral shield 300, such asshown in FIGS. 3 and 6.

The energy transducer module driver 209 can comprise any LED-poweringand controlling circuitry, whether configured as an actual printedcircuit board, an integrated circuit, or discrete components. In someembodiments, it serves the function of an LED driver, providing acontrolled current, voltage or power level through the LED emitters 207within the LED specifications to provide a desired illuminationintensity therefrom. Optionally, the LED printed circuit board caninclude a pulse-width modulation function, PID circuit, or similarscheme in order to modulate the effective intensity of the emissionsover time to achieve a desired heating of a target region of the eyelid.

The energy transmission surface 140 can be positioned relative to thehousing 202 at a location distal to the energy transducer module 120,and positioned in between the energy transducer module 120 and thetissue treatment site of the eye system 10. Positioned in this manner,the energy transmission surface 140 can pass, or receive and transmit,the electromagnetic energy transmitted from the energy transducer module120. The energy transmission surface can be a concave shape, such thatthe energy transmission surface 140 corresponds to the shape of theeyelids 12, 14 when closed and covering the eyeball 20. The energytransmission surface 140 may be an integral part of housing 202 and maysubstantially seal the distal end of the eye treatment device 200.Additionally, energy transmission surface 140 may move independently, orwith energy transducer module 120, relative to housing 202. A sealingelement such as a bellows, gasket, o-ring or similar sealing means maybe used to prevent contamination of the interface between the movableelements and the housing.

In some embodiments, the energy transmission surface 140 is positionedadjacent to the eyelids 12, 14, and does not physically contact theeyelids 12, 14, but instead transfers heat to the treatment tissueradiantly. The energy transmission surface 140 can be substantiallytransparent to the desired electromagnetic energy transmitted by theenergy transducer module 120 to allow for the transmission of thethermal energy from the energy transducer module 120 withoutsignificantly hindering the desired energy type or wavelength fromreaching the treatment tissue. In some embodiments, the energytransmission surface 140 can be made of an optical plastic, sapphire,glass, calcium fluoride, or fiberglass. It can have an easy to cleanoutside surface and can be scratch resistant. In some embodiments, theenergy transmission surface 140 can be configured to operate inconjunction with the energy transducer module 120 to filter unwantedwavelengths from reaching the treatment tissue or other portions of theeye system 10. For example, in some embodiments, the illumination sourcemay transmit electromagnetic energy in both the IR and visible lightspectra. The energy transmission surface 140 can be used to allowpassage of, for example, the energy from the visible light spectrum, butfilter out the energy from the IR spectrum. Likewise, if it is desiredthat only energy from one color reach the treatment tissue, the energytransmission surface 140 can be used as a bandpass filter or be usedwith a filter to restrict passage of energy of wavelengths other thanthe color desired. Alternatively, as described previously, energytransmission surface 140 may include a single-use cover element 147.Such cover element 147 may be transparent to all relevant wavelengths oflight or other forms of energy, or it may have desirable filteringproperties, and it may additional include a temperature or pressuresensor.

In some embodiments, the energy transmission surface 140 can beconfigured to come in physical contact with the eyelids 12, 14 and mayconductively transfer heat to the treatment tissue (or facilitatecooling of the eyelid, as described below). In other embodiments, apreponderance of tissue heating occurs as a result of radiant heatingfrom the energy transducer module 120, wherein substantially all of thedesired electromagnetic energy passes through energy transmissionsurface 140 and is absorbed by the tissue, thereby causing heating ofthe tissue and little or no heating of the energy transmission surface140. It will be appreciated that the device may be configured without anenergy transmission surface 140. However, the energy transmissionsurface 140 provides certain benefits such as ease of cleaning of theprimary patient contact surface, as well as the potential for the energytransmission surface 140 to assist in keeping the outer surface of theeyelid within a desired temperature range, and to provide a convenientlocation for certain safety sensors. In embodiments where a single-usecover element 147 is used as part or all of the energy transmissionmodule 140, the cover element 147 may contain a temperature sensor, butpreferably a non-contact temperature sensor is utilized instead, such asa thermopile or pyroelectric sensor, positioned proximal (relative tothe housing) to the cover element 147. In such embodiments, the coverelement 147 is preferably transparent to the wavelengths of infraredthat the non-contact temperature sensors are designed to sense.

FIG. 4B is a schematic front plan view of the energy transducer module120 of the eye treatment device 200. As shown in FIG. 4B, the LEDemitter 207 can be arranged as an array of individual LEDs. Asrepresented, the LED emitter 207 is arranged in a 3×3 array of LEDs(such as in the LZ9 configuration offered by LED Engine, Inc.), thoughthe LED emitter 207 is not limited to this arrangement and can includearrays of varying numbers of LEDs arranged in varying arrays of columnsand rows; and some embodiments may include a single LED or other type ofillumination source. The reflector 210 may partially or fully surroundthe LED emitter 207, such that it can direct the emission of light fromthe LED emitter 207 in a desired manner. The lens 208 can be positionedover the LED emitter 207 and positioned within the internal diameter ofthe reflector 210.

FIG. 4C is a schematic side plan view of one embodiment of an eyetreatment device 200, wherein the device is operational and transmittinglight 211 to the eye system 10 and the treatment tissue. In FIG. 4C, thelight beams 211 are emitted from the energy transducer module 120. Someportion of the light beam 211 may initially be radiated at an angle suchthat light, without correction, would not reach the energy transmissionsurface 140 for passage to the treatment tissue. As shown, the reflector210 may reflect or guide the angled light towards the energytransmission surface 140, thereby improving the efficiency of heatingthe target tissue. Portions of the light beam 211 may also betransmitted directly from the energy transducer module 120 to the energytransmission surface 140.

FIG. 4D is a schematic side plan view of another embodiment of an eyetreatment device 200. In this embodiment, the transmission of the lightbeam 211 may be administered without the aid of a reflector 210, if, forexample, other components of the eye treatment device 200 can be used tocontrol the direction and intensity of the light beam 211 such as aspecially shaped lens 208, an additional lens element, a light pipe, atotal internal reflective (TIR) element, a refractive element, adiffractive element, a mirror element, a diffuser, and the like, or acombination thereof. It may be desirable in this manner to control thefocus and the intensity of the light energy so that the light energypenetrates deeply into, but not significantly beyond, the target tissuein the eyelids 12, 14, such as the meibomian glands. In someembodiments, the energy transmission surface 140, acting as a lens orwith a lens, may be used to focus and direct the light beam 211 to thedesired treatment tissue and away from the central ocular axis, to avoidthe anterior eye structures 27 of the eyeball 20 and other sensitiveanatomy of the eye such as the retina. It will be appreciated that theregion along which the upper eyelid 12 and lower eyelid 14 meet may varyfrom one individual to another; in most individuals the region isgenerally below the central ocular axis. However, for purposes ofdemonstrating how certain embodiments can mitigate the risk of excessivelight rays 211 penetrating the eyelids at the central ocular axis, theworst-case situation of having the eyelids meet at the central ocularaxis is shown. It will be further appreciated that at least some of therisk associated with excessive rays penetrating the eyelids and reachingsensitive tissues may be mitigated by having the individual beingtreated move his/her eyeball off-axis, such that most of the rayspenetrating the eyelids only reach the sclera, which is generally lesssensitive.

FIG. 4E shows a particular embodiment comprising additional opticalelements to improve the distribution of light energy across the eyelidsurface, while minimizing the amount of light passing directly throughthe central ocular axis. Energy transducer module 120 comprises an LEDsuch as an LZ9 from LED Engin Inc., a prism 280, a shaping lens 282, andface glass 284 (serving a similar function as energy transmissionsurface 140 in other embodiment disclosed herein). Eyelids 12, 14 andeye 20 are also shown in relation to the optical elements. In thisparticular design, the prism is a glass element with 6 polished surfacesand one half ball concave surface with radius 3.5 mm to accommodate theLED. There is no coating on the prism surfaces. Entrance and exitsurfaces can have anti-reflection coating (optional) which increases theefficiency by about 5-6%. FIGS. 4F-H show exemplary details of the shapeand dimensions of prism 280. The material may be BK7, and the surfacesare preferably polished. FIG. 4F is a front view, FIG. 4G is a sideview, and FIG. 4H is a section view through section A-A. FIGS. 4J-M showexemplary details of the shape and dimensions of shaping lens 282. FIG.4J is a front view, FIG. 4K is a section view through section A-A, FIG.4L is a side view, and FIG. 4M is a perspective view. FIGS. 4N and 4Pshow the theoretical optical performance of the system described inFIGS. 4E-M above. FIG. 4N shows the light distribution, measured asirradiance in Watts per square millimeter, on the surface of theeyelids, wherein the light distribution is shown to be fairly uniform(as opposed to shining the LED of energy transducer module 120 directlyat the eyelids or through a plain glass energy transmission surface, inwhich case most of the light would be projected in the middle of the lidand very little would reach the edges). The total calculated flux is0.86 Watt, the maximum irradiance is 2.2 milliwatts per squaremillimeter and the uniformity is estimated at about 80%. FIG. 4P showsthe amount of irradiance reaching the eye (i.e., passing through theeyelid tissue). The total calculated flux is 0.019 Watts, and themaximum irradiance is 0.18 milliwatt per square millimeter.

FIGS. 5A and 5B are representative of one embodiment of an eye treatmentdevice 200. FIG. 5A is a schematic side plan view of the eye treatmentdevice 200 and FIG. 5B is a schematic front plan view of the eyetreatment device 200. The embodiment of the eye treatment device 200 maycontain components similar to those shown in FIGS. 4A-4C, including thepower source module 110 and the controller 212, though such componentsare not shown in FIGS. 5A and 5B. FIG. 5A provides a differentconfiguration for the energy transducer module 120 in order to focus andcontrol the direction of the light beams 211. In some embodiments, theeye treatment device 200 can include multiple energy transducer modules120, such that at least one energy transducer module 120 a can bepositioned in an upper region of the eye treatment device 200 to provideelectromagnetic energy (e.g., light beams 211) to the target tissuewithin the upper eyelid 12 and at least one energy transducer module 120b can be positioned in a lower region of the eye treatment device 200 toprovide electromagnetic energy (e.g., light beams 211) to the targettissue residing in the lower eyelid 14. Having separate energytransducer modules 120 a, 120 b positioned separately in the eyetreatment device 200, allows the eye treatment device 200 to directlight energy directly toward the target tissue within the upper eyelid12 and the lower eyelid 14 and reduces the amount of light that may bedirected towards sensitive anterior eye structures 27 along the centralocular axis 30.

As shown in FIG. 5A, use of the eye treatment device 200 for treatmentof an eye condition such as MGD and blepharitis, can include positioningthe energy transmission surface 140 of the eye treatment device 200adjacent to, or in contact with, the closed upper and lower eyelids 12,14 of a patient. With the eye treatment device 200 positioned in thisway, the upper energy transducer module 120 a can be positioned abovethe central ocular axis 30 to provide electromagnetic energy in the formof light beams 211 to the meibomian glands 18 within the upper eyelid12, and the lower energy transducer modules 120 b can be positionedbelow the central ocular axis 30 to provide electromagnetic energy inthe form of light beams 211 to the meibomian glands 18 within the lowereyelid 14. The eye treatment device 200 can also include a reflector 210positioned behind the upper and lower energy transducer modules 120 toreflect back any light to the treatment tissue.

As depicted in FIG. 5A, the upper and lower energy transducer modules120 can be tilted at an angle, each having a central optical axisdirected substantially at an oblique angle to the surface of eacheyelid, such that the majority of light energy passing into each eyelidis absorbed before reaching the sensitive anterior eye structures 27 ofthe eyeball 20. In some embodiments, the upper and lower energytransducer modules 120 can have other directional orientations. Forexample, in some embodiments, the upper and lower energy transducermodules 120 can be positioned such that each central optical axis of theillumination sources is substantially horizontal. As such, the lightbeams 211 transmitted from the energy transducer modules 120 configuredin this way can travel horizontally from the energy transducer modules120 to the energy transmission surface 140 and may then be refracted,diffracted, or reflected at an angle toward the treatment tissue, in amanner that maximizes penetration, absorption and heating in thetargeted regions of the eyelids while minimizing the proportion of lightthat reaches the sensitive anterior eye structures 27.

The eye treatment device 200 of the embodiments shown in FIGS. 5A and 5Bcan include more than one energy transducer module 120 in each of theupper and lower regions of the eye treatment device 200. For example, asshown in FIG. 5B, the eye treatment device 200 can include threeseparate energy transducer modules 120 a-c in the upper region and threeseparate energy transducer modules 120 d-f in the lower region. Othernumbers of energy transducer modules 120 are contemplated, such as, forexample 2, 4, 5, 6, 7, 8, 9, 10, etc. energy transducer modules 120 ineach of the upper and lower regions of the eye treatment device 200.Positioning multiple energy transducer modules 120 laterally in theupper and lower regions of the eye treatment device 200 allows forimproved coverage and distribution of the electromagnetic energy acrossthe width (side-to-side) of the upper and lower eyelids 12, 14 to betterreach the full width of the target tissue (e.g., the meibomian glandswithin the eyelids 12, 14). Also as shown in FIG. 5B, the upper andlower energy transducer modules 120 a-c, 206 d-f can be arranged in anarc pattern to follow the upper and lower contours of the eyeball.

It is also contemplated, though not depicted in FIG. 5B, that the upperand lower illumination regions of the eye treatment device 200 can befitted with more than one row of energy transducer modules 120. Forexample, in FIG. 5B one or more additional energy transducer modules 120could be positioned above or below each of the energy transducer modules120 a-c. Including additional rows of energy transducer modules 120 a-ccan provide additional vertical coverage and distribution of theelectromagnetic energy directed to the target treatment tissue. It isadditionally contemplated, though not depicted, that the device 200 mayinclude two sets of energy transducer modules 120, reflectors 210, andenergy transmission surfaces 204 within a housing, configured likebinoculars, to be positioned adjacent to, or against, both of apatient's eyes simultaneously. Devices of such embodiments may speed upthe treatment time, as both eyes can be treated at the same time.

FIGS. 5C-F show side, top, front and perspective views, respectively, ofan 8-LED configuration, similar to that depicted in FIGS. 5A-B (onlywith eight LEDs instead of six). The eight LEDs 120 may be of an LZ1type from LED Engin, Inc., and are shown arranged on a sphericallycurved surface, which may be a circuit board or an energy transducermodule driver 209, positioned behind face glass 284 whose shape matchesthe curvature of eyelids 12, 14 adjacent to eye 20. FIG. 5G shows thecalculated irradiance pattern onto eyelids 12, 14, with a total flux of2.7 Watts and a maximum irradiance of 10.7 milliwatts per squaremillimeter. FIG. 5H shows the calculated irradiance passing through theeyelids, with a total flux of 0.07 Watts and a maximum irradiance of 0.6milliwatts per square millimeter. It will be appreciated that thepattern of irradiance in FIG. 5G and 5H are less uniform than thepatterns shown in FIGS. 4N and 4P. The trade-off between the two designsis compactness of the device versus uniformity. The designs of FIGS.4E-L include a rather large prism, while the designs of FIGS. C-F do notinclude any optical elements other than the LEDs and lenses and the faceglass. Those skilled in the art may combine the two approaches, forexample, by adding one or more prisms 280, shaping lenses 282, or otherelements such as diffusers, gratings and the like, to the designs ofFIGS. 5C-F, in order to optimize the uniformity of light distributionwhile keeping the size of the device as compact as possible.

FIG. 6 is a schematic side plan view of an eye treatment device 200,such as the eye treatment device 200 depicted in FIG. 5A. Also shown inFIG. 6 is a scleral shield 300, which, in conjunction with the eyetreatment device 200, can provide a system of treating the target tissuewith increased safety and efficacy. The scleral shield 300 can bepositioned under eyelids 12, 14 and adjacent to the patient's eyeball 20to cover sensitive anterior eye structures 27. For example, the scleralshield may be positioned (referring to FIG. 1) over the sclera 21 andcornea 22 and may also provide protection to other internal anatomy ofthe eye such as the iris 24, pupil 25, lens 25, and other lightsensitive anatomy of the eye system 10.

Referring back to FIG. 6, the scleral shield 300 may be of similar discshape as a contact lens, or it may be substantially larger to cover theentire cornea and optionally at least some of the sclera (as in the caseof a conventional corneal shield), or it may have a partial disc orpaddle shape, similar to the under-lid portion of a Mastrota paddle.Shield 300 may be positioned in the eye prior to treatment with the eyetreatment device 200, or it may be integral with device 200, andtherefore placed in the eye or under the lid during the treatment. Inaddition to providing basic safety benefits, the scleral shield 300 canalso allow for increased efficacy of the eye treatment device 200. Forexample, in some circumstances, the intensity of the energy emanatingfrom the energy transducer modules 120 must be modulated to preventinjury to the sensitive eye anatomy; however, when the eye anatomy isprotected by the use of the scleral shield 300, the intensity of theelectromagnetic energy directed from the energy transducer modules 120can be increased. As shown in FIGS. 7E-7G, the scleral shield 300 mayinclude a top curved portion 264 of the shield that prevents scatteredphotonic energy from reaching the cornea, lens, iris and pupil. Thoughthe scleral shield 300 is shown in FIG. 6 to be used in the conjunctionwith the embodiment of the eye treatment device 200 described inrelation to FIGS. 5A and 5B, it will be appreciated by the skilledartisan that the scleral shield 300 can be used in conjunction with anyof the embodiments of the eye treatment device 200 disclosed herein tocreate a system for safe and efficacious treatment of eye disorders.

It will be further appreciated that the scleral shield 300 may includefeatures which provide even more benefits to the device. For example,the scleral shield 300 of some embodiments is configured to reflectenergy away from the eyeball and toward the inner eyelids, providingheating to the inner eyelids. In some embodiments, the scleral shield300 may also include an image translator 155, as discussed above. Thereflective imager 155 allows viewing of the inner side of the eyelid 14and transillumination of the meibomian glands from behind the eyelid. Insome embodiments, the scleral shield 300 may be made of anenergy-absorbing material or have an energy transmission surface on afront face 302 for heating the meibomian glands from behind the eyelidduring treatment. The energy-absorbing material may be a visible lightor IR-absorbing material or surface made of black plastic or coated witha black substance, either of which may contain carbon black (e.g. 5% ormore) or other material which absorbs light energy such as red light andNIR.

Additionally, as shown in the schematic front plan views of the scleralshield 300 in FIGS. 7A-7H, the shield 300 may incorporate one or moretemperature sensors 310 on the front or back surfaces of the shield 300.The shield 300 may also include data transmission means 320, so thattemperature data may be sent to the treatment device 200 in order tomonitor or modulate the treatment session, so that the inner surfaces ofthe eyelids may reach a target temperature without exceeding apredetermined threshold, along with ensuring that the sensitive tissuesof the eye do not exceed another predetermined threshold. In someembodiments, such as the embodiment of FIG. 7A, the shield 300 has anembedded power source 330, an array of temperature sensors 310, and adata transmission means 320, which transmits data wirelessly, such as byRF, to an external interrogator 400 (which may be incorporated into thetreatment device 200). In some embodiments, the data transmission means320 includes an antenna embedded in the shield 300. In anotherembodiment, such as the embodiment depicted in FIG. 7B, the shield 300may be passive (without a power source 330) and configured to beinterrogated by an external interrogator 400 (which may be incorporatedinto the treatment device 200) using RF. For example, the externalinterrogator 400 shown schematically in FIG. 7B may be configured toprovide power to circuitry in the shield 300 adequate to measure thetemperature(s); the interrogator 400 may also provide power to atransmitter to send the temperature data back to the interrogator 400.In yet another embodiment, such as the embodiment of FIG. 7C, the shield300 may be fully passive and contain one or more temperature sensors 310in resonant circuits whose points of resonance will be modulated bychanges (such as resistance) in the temperature sensors 310, and whosepoints of resonance can be detected by sweeping an external RF field,for example using the external RF sweeper 410 depicted schematically inFIG. 7C, and monitoring the impedance or other characteristic of thefield. In a further embodiment, such as the embodiment of FIG. 7D, theshield 300 may be physically linked to an external device such as aninterrogator or treatment device 200 (e.g. of FIG. 3) via a wire or wirearray 420 extending from the shield 300 to an external device, whereinsuch external device may provide power to the active elements in theshield 300 and send and receive data to and from the shield 300. Wire orwire array 420 may comprise conventional stranded or solid wireconductors with thin-wall insulation, or they may be embedded in moresubstantial structural insulation.

FIGS. 7E and 7E are schematic side and front plan views of the shield300 having a temperature sensor 310 in the middle and one wire 420coming out of each side of the shield. The upper curved portion of theshield 264 is used to protect the patient's cornea, lens, iris and pupilfrom the light or IR energy. The temperature data from the temperaturesensor 310 may be sent to the treatment device 200 via the wires 420 inorder to monitor or modulate the treatment session, ensuring that theinner surfaces of the eyelids reach a desired temperature range withoutexceeding a predetermined threshold, along with ensuring that thesensitive tissues of the eye do not exceed another predeterminedthreshold.

FIGS. 7G and 7H are schematic side and front plan views of the shield300 having a temperature sensor 310 in the middle and one wire 420coming out of each side of the shield. In these embodiments, scleralshield 300 may be coupled to the housing 202 with one or more supportarms 262, with the wires being positioned on or within the arms, and, incertain embodiments, with the structural portion of support arms 262made from insulating materials surrounding or otherwise channeling theconductive portions of wire or wire array 420.

FIG. 8 depicts a side view of another embodiment of an eye treatmentdevice 200. In some embodiments, such as the presently depictedembodiment, the eye treatment device 200 is configured to apply energyto one eyelid at a time in order to further protect the tissue of theeye from harm or discomfort. In such a configuration, the energytransducer module 120 within the housing 202 is sized to target themeibomian gland and surrounding tissue of one eyelid, for example, theupper eyelid 12 of FIG. 1 or the lower eyelid 14 of FIG. 1 and theenergy transmission surface 140 is in a slidable relationship alongmovement path 145 with the energy transducer module 120. In suchembodiments, the energy transmission surface 140 is also sized forplacement along one eyelid at a time. In use, a patient using such aneye treatment device 200 may be instructed to open an eye widely, thusensuring that the eyelid is relatively far away from the sensitiveanterior eye structures and the central ocular axis.

In some embodiments, the eye treatment device 200 includes one or morefeatures to help ensure the eye treatment device 200 is safely andproperly placed against the eyelid. For example, in some embodiments,the eye treatment device 200 includes a pupil alignment guide 242. Thepupil alignment guide 242 may be, for example, a mirror with a circle,X, bull's-eye, or other target mark. In use, a patient may be able toproperly position their eye by looking into the pupil alignment guide242, observing the reflection of their pupil in the mirror, and aligningthe pupil with the target mark. Additionally or alternatively, in someembodiments, the eye treatment device 200 includes a display 244, whichmay be a screen, a digital display, or other optical display. Thedisplay may present, for example, an image for the patient to stare atduring use, a timer counting down the remaining treatment time, and/orreminder messages such as “Look Up” (explained below). The display 244may also include a visualization means 160 for enhanced monitoring ofeyelid margin during diagnosis and treatment.

The eye treatment device 200 of FIG. 8 may include any or all of thefeatures described in relation to other embodiments presented herein.For example, in the depicted embodiment, the energy transducer module120 is an infrared LED array. However, in other embodiments, includingother embodiments configured to apply energy to one eyelid at a time,the energy transducer module 120 may include an LED emitting light inthe visible light spectrum, a laser, an incandescent lamp, a xenon lamp,a halogen lamp, a luminescent lamp, a high-intensity discharge lamp, ora gas discharge lamp. The eye treatment device 200 may further include ascleral shield 300 made of an energy-absorbing material or have anenergy-absorbing or energy transmission surface on a front face 302 forabsorbing or transmitting heat and warming the inner surface of theeyelid during treatment. The scleral shield 300 may also incorporate oneor more temperature sensors 310 in order to monitor the treatmentsession, ensuring that the inner surfaces of the eyelids reach a desiredtemperature and/or do not exceed a predetermined threshold. The scleralshield 300 may further include an image translator 155 integrated intothe scleral shield, allowing viewing of the meibomian glands behind theeyelid. The eye treatment device 200 of FIG. 8 preferably also includesa power source module 110 and optionally a controller 212, along withother components as described in relation to various embodimentspresented herein. Additionally, the eye treatment device 200 of FIG. 8includes a reflector 210. In the depicted embodiment, the reflector 210is formed of a barrel and backplate, which together surround the energytransducer module 120 in all but a distal direction.

The eye treatment device 200 of various embodiments also includes one ormore thermal management structures configured to cool at least a portionof the device. In some embodiments, the thermal management structuresare provided to manage the heat of the energy transducer module 120 andprevent the device 200 from overheating. Additionally or alternatively,in some embodiments, the thermal management structures are provided tocool a surface of the eyelid to limit discomfort and avoid injury to theeyelid tissue during treatment. In FIG. 8, for example, the eyetreatment device 200 includes a thermal management structure 220 (shownas a finned heat sink), a thermoelectric (Peltier) module 224, and oneor more thermally conductive surfaces that are passively or activelycooled. In some embodiments, a passive heat sink may be provided as anadequate thermal management structure 220 to dissipate heat from theenergy transducer module 120 into the surrounding environment withoutthe need for a thermoelectric module 224. Some embodiments include athermoelectric module 224 or other type of cooler (such as a compactvapor-compression cooler) designed to cool the energy transducer module120 by transferring heat directionally away from the energy transmissionsurface 140. In FIG. 8, the thermoelectric module 224 and thermalmanagement structure 220 are coupled such that the thermoelectric module224 pumps heat away from the energy transducer module 120 towardsthermal management structure 220 for dissipation. Additionally oralternatively, some embodiments include one or more thermally conductivesurfaces. For example, in FIG. 8, the barrel and backplate of thereflector 210 are thermally conductive and coupled to both the energytransmission surface 140 and the thermoelectric module 224. Moreover,the energy transmission surface 140 is thermally conductive. As aresult, heat from the surface of the eyelid and the energy transmissionsurface 140 can be pulled towards the thermoelectric module 224 to helpmaintain a comfortable temperature against the eyelid. Actively coolingthe energy transmission surface 140 may occur not only during the heattreatment period, but before, after or intermittently, as a means ofcooling the eyelids. Such a feature may not only provide relief from theburning and itching sensation that often accompanies MGD andblepharitis, but may also provide reduction of inflammation of theeyelids.

In some embodiments, the eye treatment device 200 includes a non-contacttemperature sensor 232 to be used, for example, in conjunction with oneor more thermal management structures. The non-contact temperaturesensor 232 may be a remote reading IR thermometer or other suitabletemperature sensor. The non-contact temperature sensor 232 can befocused on a region of the eye of particular interest. For example, inFIG. 8, the non-contact temperature sensor 232 is focused on a bottomedge of the cornea, and thus, provides a reading of the temperature atthe cornea's edge. The non-contact temperature sensor 232 may beoperatively coupled to a controller 212 such that, in some embodiments,the controller 212 modulates or shuts down the energy transducer module120 or activates one or more thermal management structures in responseto receiving an elevated temperature reading from the non-contacttemperature sensor 232. In some embodiments, while heat is being appliedto the lower eyelid (for example), the display 244 may instruct thepatient to “Look Up” in order to allow the non-contact temperaturesensor 232 to measure the temperature of the eye (sclera) at a locationthat is directly behind the portion of the eyelid being heated. In thismanner, the device 200 can continue to heat the eyelid whileperiodically ensuring that the eyeball is not being overheated. It willbe appreciated that the device configuration shown in FIG. 8 may easilybe adapted for treating the upper eyelid, for example by reversing theorientation of the energy delivery elements while keeping the display244 and alignment elements in their upright (readable) orientation.

FIG. 9 depicts a side view of another embodiment of an eye treatmentdevice 200 having one or more thermal management structures 220. Any ofthe thermal management structures 220 described with reference to FIG. 8or 9 are suitable for use, and expressly contemplated for use, with anyof the eye treatment device 200 embodiments described herein. Thethermal management structure 220 may include any suitable structureconfigured to remove heat from the energy transducer module 120 so thatthe energy transducer module 120 remains within a desired temperaturerange to maintain efficiency of the energy transducer module 120. Insome embodiments, the thermal management structure 220 is disposed atleast partially within the housing 202 of the device 200, along with thepower source 110 and other internal components. In some embodiments, oneor more of the following thermal management structures 220 are providedwithin the housing 202: a heat sink (e.g., the finned heat sinkembodiment of thermal management structure 220 shown in FIG. 8), athermoelectric (Peltier) module (e.g., the thermoelectric module 224 ofFIG. 8), a compact vapor-compression module, and a fan. In someembodiments, the thermal management structures 220 direct and distributethe heat in a manner that keeps the housing 202 cool to the touch.

Additionally, in some embodiments, the eye treatment device 200 includesa surface cooling system designed to prevent the eyelid surface fromheating to the point of discomfort or injury while the target tissuebelow the surface is being heated. A surface cooling system is notneeded in all embodiments; for example, in some embodiments, theselected energy transducer module 120 is configured to emit light energyat a wavelength that is absorbed into a target tissue region within theeyelid or an energy-absorbing portion of a scleral shield with minimalheating of an eyelid's surface tissue. In embodiments in which a surfacecooling system is present, the surface cooling system may be configuredto cool the surface of a patient's eyelid to or below body temperatureor to a temperature below the target tissue temperature or below athreshold of discomfort before, during, or after delivery of energy tothe target tissue region. The surface cooling system may include anysuitable structure configured to cool a surface of the eyelid and/orcool the energy transmission surface 140. For example, in someembodiments, the surface cooling system includes an active coolingelement, such as a fan. In some such embodiments, the energytransmission surface 140 is shaped such that an air gap exists betweenthe energy transmission surface 140 and at least a portion of theeyelid. FIG. 2B depicts an embodiment appropriately structured for thispurpose. In such embodiments, air may be blown within the air gap acrossthe surface of the eyelid. In other embodiments, the energy transmissionsurface 140 may have one or more holes or channels extending through oralong the energy transmission surface 140, through which air can beblown. In some embodiments, air is cooled before being blown across thesurface of the eyelid. The air may be cooled, for example, using athermoelectric cooler, compressor, ice, or other chilling element.

In other embodiments, an evaporative agent such as water or alcohol maybe applied to the energy transmission surface 140, such that a surfaceof the eyelid then comes into contact with the evaporative agent.Additionally or alternatively, an evaporative agent may be applied tothe surface of the eyelid before, during, or directly after treatmentwith the eye treatment device 200. As evaporation occurs on the surfaceof the eyelid as a consequence of the evaporative agent, a cooling andrelieving sensation may be experienced by the patient. In still otherembodiments, the eye treatment device 200 may include a cooling bladderpositioned between the energy transmission surface 140 and the surfaceof the eyelid. The bladder may be filled with a cool water or gel andprovide a cooling and relieving sensation to the patient when thebladder is in contact with the surface of the eyelid. As anothernon-limiting example, the surface cooling system may include the energytransmission surface 140 itself. In some such embodiments, the energytransmission surface 140 may be formed from an energy-absorbingmaterial, such as, for example, diamond, sapphire, calcium fluoride, orgraphene, and thermally linked to a larger thermal mass. Such largethermal masses take a long time to heat, and thus, may not heat upsignificantly during a treatment period. The large thermal mass may,therefore, sink heat away from the energy transmission surface 140during a treatment period. In addition, the large thermal mass may becooled prior to, or during, the treatment period, and may also be formedfrom the same materials, and as part of, the energy transmission surface140, or it may be formed as a separate element out of materials such ascopper, aluminum, or other energy-absorbing or conducting material.

In addition to the thermal management structures 220 and surface coolingsystems described above, at least some eye treatment devices 200 includeone or more safety sensors 230, for example, to monitor parameters ofthe eye treatment device 200 or to ensure patient safety. FIG. 10provides one example of an eye treatment device 200 having one or moresafety sensors 230. Any of the safety sensors 230 and relatedcontrollers 212 described with reference to FIG. 10 are expresslycontemplated for use with any of the eye treatment device 200embodiments described herein. Any particular eye treatment device 200may include one or more types of safety sensors 230. A first set ofsafety sensors 230 provided in FIG. 10 are configured to sensetemperature. Such safety sensors 230 include a non-contact temperaturesensor 232 and a thermocouple or thermistor 234. The non-contacttemperature sensor 232 may be a remote reading IR thermometer (such as athermopile or pyroelectric or microbolometer) or other suitablenon-contact sensor. The non-contact temperature sensor 232 may bedesigned to gather temperature data from the full field of illumination,such as during a treatment period, to monitor the surface temperature ofone or more eyelids, or it may be designed to focus on a particularregion and provide a temperature reading of that region. For example,the non-contact temperature sensor 232 may be positioned and configuredto provide a temperature reading of a portion of the cornea, sclera, orother region of the eye, to ensure such tissue is not overheated anddamaged, as is depicted in FIG. 8, for example.

Additionally or alternatively, some embodiments include a thermocoupleor thermistor 234 (or RTD) positioned on or near the energy transducermodule 120. Such a placement allows the thermocouple or thermistor 234to detect the temperature of the energy transducer module 120 so thatthe temperature of the energy transducer module 120 can be monitored. Ifthe energy transducer module 120 runs too hot, it can become inefficientand/or damaged. Additionally or alternatively, a thermocouple orthermistor 234 may be disposed on, within, or adjacent to the energytransmission surface 140. Such a placement allows the thermocouple orthermistor 234 to detect the temperature of the energy transmissionsurface 140 and/or the surface of an eyelid. Monitoring the temperatureof such surfaces may help to ensure that a patient does not experiencesignificant discomfort or injury from use of the device 200. In certainembodiments, the various temperature sensors 232, 234 are operativelycoupled to a controller 212, which may be programmed to modulate theoutput of the energy transducer module 120 or one or more thermalmanagement structures or surface cooling systems, in order to bring orhold the temperature to within a predetermined target range. Also, ifthe temperature inputs from the temperature sensors 232, 234 are abovethe predetermined range, the controller 212 may turn off the output fromthe energy transducer module 120. Additionally or alternatively,temperature sensors 232, 234 may be coupled with the scleral shield 300(not shown in this figure) to monitor the temperature of the innersurface of the eyelid and/or surface of the eye. Additionally, apressure sensor or sensors 221 may be disposed on, within, or adjacentto the scleral shield 300 and/or the energy transmission surface 140 tomonitor the pressure or force applied by the user on the eyelid.

A second set of safety sensors 230 present in FIG. 10 are provided tosense the position of the eye treatment device 200 relative to theeyelid of a patient. A light sensor 236 present in, on, or near theenergy transmission surface 140 is configured to detect light. Invarious configurations of the device 200, when the energy transmissionsurface 140 is properly placed adjacent to one or two eyelids, dependingupon the configuration, it should significantly reduce the amount ofambient light that can reach the light sensor 236. In some embodiments,if light is detected in, on, or near the energy transmission surface 140above a threshold range, it is an indication that the energytransmission surface 140 is not properly placed. Similarly, contactsensors 238 may be present in or on the energy transmission surface 140.Each contact sensor 238 may be configured to detect changes incapacitance, such as, for example, the change in capacitance that occurswhen a contact sensor 238 is near human skin. Alternatively, contactsensors 238 may comprise electrodes that apply a small DC or ACmicrocurrent and which sense changes in impedance a result of contactwith skin. Or, contact sensors 238 may comprise microswitches or forceor pressure sensors, all of which produce a change in signalcharacteristics when surface 140 is against skin. Thus, sensors 238 canbe used to help determine the placement of the device 200. If the eyetreatment device 200 is properly placed against a closed eye, an uppercontact sensor 238 and a lower contact sensor 238 should each come intocontact with the skin of an eyelid and sense a change in capacitance (orimpedance, switch status, force, pressure, etc.). In variousembodiments, the light sensor 236 and/or contact sensors 238 areoperatively coupled to a controller 212. In some such embodiments, thecontroller 212 is programmed to prevent activation of the energytransducer module 120 until the controller 212 detects, through signalsfrom the sensors 236, 238 that the eye treatment device 200 is properlyplaced adjacent to a closed eye. Additionally, in some embodiments, thecontroller 212 is programmed to shut off the energy transducer module120 if signals received from the sensors 236, 238 indicate that the eyetreatment device 200 is no longer placed properly against a closed eye.Additionally, or alternatively, thermocouples or thermistors 234 on, inor adjacent to energy transmission surface may be used to indicate whenthe device is properly positioned adjacent to a patient's eye. Forexample, the thermocouples or thermistors 234 may register roomtemperature prior to placement of the device adjacent to the eye, and asthe energy transmission surface 140 comes into contact with the eyelidskin (in embodiments where direct contact is desired), the thermocouplesor thermistors 234 will register a value closer to body temperature, andtherefore, confirm proper positioning. Further, if multiplethermocouples are used in embodiments which treat both the upper andlower eyelid, the data from the thermocouples or thermistors 234 may beused to determine if the eye is open or closed. A reflective or colorsensor 237 may also be incorporated into the device in order to confirmthat the eye is closed. Such a sensor 237 can either determine the colorof a region of the optical field in front of the sensor 237, or it candetermine the degree of reflection of the surface in front of thereflective or color sensor 237. In either case, the sensor 237 providesdata indicating whether or not there is tissue that appears to be eyelidskin (e.g., flesh colored and not wet or shiny) or eye tissue (white oriris colored, and wet and shiny).

In some embodiments, contact sensor 238 comprises a microswitch embeddedbehind a flexible, sealed surface. In other embodiments, contact sensor238 comprises a sensor which provides an indication of the amount offorce or pressure applied by surface 140 against the eyelid. Such anindication may be useful in order to avoid applying excessive forceduring a treatment, or to apply force within a certain range duringinitial diagnosis when the eyelid is meant to be slightly compressed toenable assessment of meibomian gland secretions. It will be appreciatedthat the force of the surface 140 against the eyelid or eyelids appliedby the clinician can be either regulated or not regulated. Further, thein-office device the force may be applied with a rolling or angularcomponent to assist in moving the meibum out of the meibomian glands andducts. In some embodiments, the energy transmission surface and/orscleral shield may have a curved or angular shape surfaces, or may havea rocking elements, such that when the energy transmission surfacecompresses the eyelid against the shield, there is initially morecompression in the lower region of the meibomian glands that graduallytransfer to the upper region as compression increases, moving meibumfrom the lower region to the upper region and then out of the meibomiangland ducts.

FIGS. 11A and 11B depict side views of additional embodiments of an eyetreatment device 200 having energy transducer 205 configured to convertelectrical energy from the power source module 110 into ultrasonicenergy. The ultrasonic energy transducer 205 may be formed from anysuitable material, such as a piezoelectric ceramic, polymer, orcomposite. In the various embodiments described above, an ultrasonicenergy transducer 205 may be used in combination with the light energytransducer module 120.

In FIG. 11A, the eye treatment device 200 includes a flat piezoultrasonic energy transducer 205 configured to emit unfocused ultrasoundwaves. While the direction of the waves is unfocused, the wavelength ofthe ultrasonic energy can still be manipulated so as to targetparticular regions of a tissue. With ultrasonic energy, the longer thewavelength, the deeper the penetration. Accordingly, in someembodiments, short, high-frequency waves of 20-100 MHz, 50-100 MHz, orany sub-range or individual value therebetween are emitted. Ultrasonicwaves of such frequencies may penetrate the tissue of the eyelid 1-3 mm.Advantageously, at such penetration depths, the meibomian glands andother surrounding target tissue can be heated without significantheating within the eye. In other embodiments, a wavelength of greaterthan 100 MHz may be emitted from the ultrasonic energy transducer 205.

The eye treatment device 200 of FIG. 11B includes one or more curvedpiezo ultrasonic energy transducers 205 configured to produce focusedultrasound waves. In some embodiments, the ultrasound waves aredirectionally focused to selectively heat a target tissue regionsufficiently to melt meibum within meibomian glands located within oradjacent to the target tissue region. In some such embodiments, theultrasound waves are targeted and directed through the use of a shapedor curved transducer having a focal point. FIG. 11B depicts one suchembodiment. In other embodiments, the ultrasound waves are targeted anddirected using a shaped array of individual ultrasonic elements. Theremay be more than one array of ultrasonic elements; for example, onearray may be directed at the lower eyelid, and another array may bedirected at the upper eyelid. It will be appreciated that in order toefficiently transmit ultrasonic energy into the target tissue, theenergy transmission surface 140 must be made from an appropriatematerial. For lower-frequency ultrasonic waves, traditional materialssuch as silicone or other polymers and elastomers may be utilized. Incertain embodiments, it may be desirable to cool the surface of theeyelid as the ultrasonic energy is applied, to prevent exceeding apredetermined threshold. In such cases, the energy transmission surface140 may be made from a material that not only can pass the ultrasonicenergy, but which is also thermally conductive (so that the coolingtechniques described previously herein may be applied). Examples ofmaterials that can pass higher-frequency ultrasonic energy as well asprovide adequate thermal conductivity include diamond or graphene.

It will be appreciated that, in addition to providing tissue heatingeffects, the ultrasonic waves may disturb, disrupt, or even kill theDemodex mites mentioned previously. As such, it may be beneficial tocombine energy modalities such as light and ultrasound in order toachieve the best overall treatment for MGD, blepharitis and relatedmaladies.

In addition to heating a target tissue region, the eye treatment device200 of certain embodiments may also be configured to send vibrationalenergy into an area that includes the target tissue region. FIG. 12provides one example of an eye treatment device 200 configured toproduce vibrational energy. The vibratory mechanism 250 embodimentsdescribed in relation to FIG. 12 are expressly contemplated for use withany of the eye treatment device 200 embodiments described herein. Theeye treatment device 200 of FIG. 12 includes a vibratory mechanism 250within a portion of the housing 202. Any suitable vibratory mechanism250 may be used. In various embodiments, the vibratory mechanism 250 isconfigured to generate a specific vibratory pattern. For example, whenheld against the eyelid of a patient, an eye treatment device 200 havinga vibratory mechanism 250 may vibrate forward and backward along an axisparallel with the central ocular axis 30. In other embodiments, the eyetreatment device 200 may vibrate side-to-side or up-and-down indirections orthogonal to the central ocular axis 30. In still otherembodiments, the eye treatment device 200 may vibrate in a circularpattern, for example, a circular pattern orthogonal to the centralocular axis 30. In some embodiments, the eye treatment device 200 mayinclude multiple settings such that a plurality of vibration patternscan be selected. The vibratory pattern may be applied to an eyelidbefore, during, or after the delivery of heat to the target tissueregion.

In some embodiments, the frequency of vibration is between about 1 Hzand about 20 KHz, but may extend into the ultrasonic frequency range upto 20 MHz, and may include any sub-range or individual valuetherebetween. Vibrations within the frequency range may help aid inexpressing meibum, which has thickened or is blocked within themeibomian glands. In addition, the vibration pattern may disturb ordisrupt the Demodex mites, thereby reducing their proliferation. It willbe appreciated that combinations of vibration and/or ultrasonic energyapplication may be employed to generate the most effective overalltreatment including tissue and meibum heating, meibum vibration andexpression, and mite disruption.

As further depicted in FIG. 12, in some embodiments, the vibratorymechanism 250 is positioned in a distal portion 203 of the housing 202.In some such embodiments, a vibratory isolation element 252 ispositioned between the distal portion 203 of the housing 202 and aproximal portion 201 of the housing 202 such that the force of thevibrations is damped in the proximal portion 201. In some embodiments, ahandle or hand gripping portion of the device 200 is located in theproximal portion 201; thus, the vibratory isolation element 252 helpslimit vibrations of a user's hand during use. In other embodiments, noisolation element 252 is present. In still other embodiments, thevibratory mechanism 250 is disposed within the proximal portion 201 ofthe housing 202, with a translational linkage between the vibratorymechanism 250 and the distal portion 203.

It should be emphasized that the foregoing specific embodiments areexemplary, and that this disclosure encompasses a large number ofvariants beyond those particular embodiments. Some of these will now bedescribed in greater detail.

When the energy transducer module 120 is an LED emitter 207, someembodiments includes the use of one or more LEDs, preferably having highintensity. For example, one or more LEDs having a combined power outputof at least 10 watts, preferably at least about 15 watts, or even 20watts or more of combined power output. The combined intensity of thoseLEDs can advantageously be at least about 20, 30, 40, 50, 75, 100, 150,200, 250, 300, 400, 500, 1000, 2000 or more lumens. When directed to theeyelid, the continuous intensity of the applied luminous energy canpreferably be between about 0.02 and 2 Watts/square-centimeter.

In some embodiments, the LEDs can be green LEDs. Green is advantageousin that it penetrates and heats tissue to the depth of about 0.5-2 mm,beyond which it is significantly attenuated. This allows the lightenergy to penetrate to the treatment area encompassing tissue at oradjacent to the meibomian glands, with limited light transmitted to theeye. Some preferred wavelengths for the light can be 495-570 nm, 500-600nm, and more preferably about 510-540 nm or 520-530 nm. In someembodiments, an infrared radiation source can be 700-1000 nm, preferablyin the “optical window” of human tissue around 800-900 nm, and morepreferably about 850 nm. Longer wavelengths would work also, potentiallytaking advantage of more absorption by water in tissue as the wavelengthincreases. For example, 3,000 nm infrared may be able to provide idealheating of the eyelid tissue with minimal penetration and heating of theeyeball and sensitive structures. In other embodiments, the LEDs can beblue, yellow, red, white, or a combination of any of the foregoing.

The energy transducer module 120 can alternatively comprise a broad ornarrow spectrum lamp, such as an incandescent lamp, a xenon lamp,halogen lamp, a cold cathode tube, a fluorescent tube, and the like. Theillumination source may further comprise a spectral limiting element toreduce the intensity of or substantially eliminate certain undesiredwavelengths from the spectrum of the lamp. Those spectral limitingelements can include colored filters, dichroic filters, IR cutofffilters, gratings, bandpass filters, spectral separating elements suchas prisms or gratings, and the like. Infrared lamps or heating elementscan also be used. The primary wavelengths allowed to reach the eyelidcan be selected as discussed above for LEDs, or can be limited primarilyto infrared radiation.

The energy emitted by the illumination source and delivered to thepatient is preferably continuous in delivery (with pulse-width or otherform of modulation, if desired), as opposed to low duty cycle,high-intensity pulsed light (such as IPL). The treatment period ispreferably for multiple seconds or minutes, e.g., 5, 7, 10, 12, 15, 18,20, 15, 30, 40, 45, 50, 60 seconds, or 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9,10, 15, 20, or even 30 minutes or more.

In some embodiments, visible light delivery from the energy transducermodule 120 can be facilitated by, or replaced with, an alternativeenergy transducer functioning as a heating modality. These can include,for example, an ultrasound transducer or a radio frequency emitter. Whenan ultrasound transducer is used, it can be either focused or unfocused.High frequencies are preferred, to limit the depth of heating, toconcentrate heating on the target tissue area comprising or adjacent tothe meibomian gland, and to reduce or eliminate effects on the eyeballor other tissue in the region. Preferred frequencies are 50-100 MHz orgreater than 100 MHz to 250 MHz. Focused ultrasound, for example, usingmultiple transducers, including phase-managed arrays to facilitatedirectional focus, or shaped transducers having a limited focal area,are particularly preferred. As with the light energy, relativelycontinuous delivery can be used, as can pulsed delivery.

When a radio frequency emitter is used, frequencies known to providelocalized heating are preferred. Frequencies used for electrosurgery,such as 300 KHz-4 MHz can be advantageously used. In one suchembodiment, bipolar electrodes are provided in or on the energytransmission surface 140 to contact the eyelid and permit control oflocation and depth of heating.

Alternatively, higher frequency radio waves, in the 5 MHz to 10 MHzrange, can be used due to their higher attenuation rate in tissue, thusallowing careful selection of penetration depth and limitation ofheating to the desired region of tissue. For example, frequencies aboveabout 245 MHz penetrate human skin and tissue to a depth of about 1-3mm, which matches the typical distance between the exterior of theeyelid and the target tissue (i.e., the meibomian glands and adjacenttissue).

The waveguide module 130 is designed to transmit energy from atransducer or generator to the energy transmission surface 140 andthence into the target tissue. For example, when creating light energyfrom a small source such as an LED or small lamp, the light waveguidemodule 130 can direct even illumination from the source to the targettissue zones. In some embodiments, it may be desirable to include awaveguide structure to direct light toward the eyelid and the targettissue without directing it along the central ocular axis of the eye.This can then reduce the amount of light penetrating into the cornea andinto the eye, while still directing the light to the eyelid, albeit at amore tangential angle. Suitable structures for accomplishing thispurpose include light pipe arrays, refractive elements, reflectiveelements, diffractive elements, total internal reflection elements(TIRs), and diffusers. For example, fiber optics, mirrors, lenses,prisms, and the like can be used to direct light and change its angle ofincidence onto a target surface (to avoid central ocular axis, forexample). In some embodiments, it may be desirable to direct lighttoward the scleral shield 300 and reflective imager 155 to view theinner side of the eyelid 14 and/or heat the meibomian glands behind theeyelid, as described above.

In another embodiment, the waveguide module 130 is an ultrasonicwaveguide having surfaces that reflect ultrasonic energy to directand/or focus it onto a desired region, e.g., the target tissue region.Similarly, a microwave or other RF waveguide of known design can be usedto direct RF energy to the desired region.

The energy transmission surface 140 is interposed between the interiorof the eye treatment device 200 and the patient, providing a barriertherebetween. It can be envisioned in some embodiments as a windowthrough which the energy is delivered to the patient. It can beconfigured to directly contact the eyelid of the patient, or to bespaced a small distance from the eyelid, such as between 0.5 mm and 12mm from the eyelid during treatment. Preferably, the exterior surface ofthe energy transmission surface is smooth and easily cleaned. In someembodiments, a single-use cover element 147 may be placed over energytransmission surface 140 in order to prevent cross-contamination betweenpatients. Element 147 may be fabricated from any suitable material suchas glass, pyrex, quartz, mica, or polymers such as polycarbonate orother optically transparent materials can be used, or a combinationthereof, in order to obtain the desired structural and opticalproperties. In some embodiments, the energy transmission surface 140 maybe in a slidable relationship along movement path 145 with respect toeither the energy transducer module 120 or scleral shield 300 or housing202, so as to ensure surface 140 can be pressed up against the eyelid oreyelids to: a) minimize photonic energy leakage during treatment andimaging, and b) if desired, apply a compressive force to the eyelidduring evaluation or expression of meibomian glands.

When using light energy to heat the target tissue region, the energytransmission surface 140 is advantageously transparent to visible orinfrared light as desired. In some embodiments, it is transparent to thepeak or desired wavelengths used for treatment, such as visible light orgreen light, but blocks infrared light, thus reducing IR heating of theeyelid. Glass, pyrex, quartz, mica, or polymers such as polycarbonate orother optically transparent materials can be used.

When heating the target tissue region with ultrasound or RF,transparency to visible light is not necessary; instead, anultrasound-transparent or RF-transparent material can be used. In someembodiments, it is desirable that the materials be thermally conductive,to facilitate cooling of the eyelid by cooling the energy transmissionsurface 140. Diamond, sapphire, and graphene are suitablethermally-conductive materials. In another embodiment, either the entireenergy transmission surface 140 or at least a window thereof istransparent to safety sensors disclosed herein. For example, where anon-contact infrared temperature sensor is used to sense the temperatureof the exterior of the eyelid, an IR-transmissive material isadvantageously used for all or at least the relevant region or regionsof the energy transmission surface 140.

When applying heating energy to the eyelid from the device 200, someembodiments includes surface-cooling the eyelid by cooling the energytransmission surface 140. If the exterior of the eyelid is cooled whileirradiating the target tissue region with light, ultrasound, or RFenergy, patient comfort can be enhanced while maximizing efficacythrough optimal heating of the target tissue. The energy transmissionsurface 140 can be cooled by: airflow across the interior of the energytransmission surface 140; application of an evaporative agent to theinside of the energy transmission surface 140, such as a refrigerant orwater; circulating a cooling fluid through channels in or on the energytransmission surface 140; or contacting the energy transmission surfacewith a thermoelectric (Peltier junction) or a heat sink linked to acooling modality. Alternatively, the energy transmission surface 140 canhave a sufficiently large thermal mass (or be in contact with such athermal mass) so as to remove sufficient heat from the eyelid during thetreatment of the patient to maintain the eyelid within a desiredtemperature range. The thermal mass can be pre-cooled or simply begin atambient temperature before the treatment. Other methods of cooling theenergy transmission surface 140 and/or the eyelid include incorporatinga reservoir between the energy transmission surface and the skin of theeyelid, such as a water-filled bladder. The bladder can be pre-cooled oractively cooled during the procedure, such as by circulation of coolwater therethrough or through using a chilling element such as athermoelectric device, a compressor, a refrigerant, or other chillingelement.

In another embodiment, the energy transmission surface 140 is spaced asmall distance from the eyelid to allow passage of a cooling fluid, suchas relatively cool air, mist, water, and the like between the energytransmission surface 140 and the eyelid. For example, cool air can beinduced to flow transversely across the surface of the eyelid and theenergy transmission surface 140, or the energy transmission surface 140can include holes or channels to direct the cooling fluid onto theeyelid. The cooling fluid can be ambient temperature or can bepre-cooled, such as through refrigeration, ice, and the like.

When a vibratory mechanism 250 is used, it can comprise, for example, areciprocating element such as an electromechanical solenoid or the like,a rotating eccentric weight, such as an eccentric weight coupled to amotor shaft, or a rotating cam. Preferably, the vibratory mechanism isvibrationally coupled to the eyelid but vibrationally isolated fromother patient or clinician contact points, such as the proximal end ofthe device 200, including any handle region that a patient or clinicianmight hold.

Patient safety and comfort are important considerations in the presentdevice and method. Safety sensors and warnings can thus advantageouslybe incorporated into the device. These include sensors for preventingoverheating of the skin, sensors for preventing undesired activation ofthe device, and sensors monitoring the delivery of energy to thepatient. In some embodiments, a safety sensor may be utilized to makesure that a consumable portion 260 having a protective scleral shield300 is in the correct position prior to turning on an energy transducermodule 120, thus preventing damage to the eye system 10.

As illustrated in FIG. 10, a safety warning apparatus 240 can beincorporated into the device to let the patient know of an unsafecondition, as sensed by any of the sensors described herein. This caninclude a flashing light, a flashing warning, a sound warning beep, apicture, a vibration pattern, or words indicative of the potential foror existence of an unsafe condition.

Again with reference to FIG. 10, a first set of safety sensors 232, 234,is preferably located on, in, in back of, or otherwise in the vicinityof the energy transmission surface 140. Both sensors are configured todetect heating of the outer eyelid surface and to prevent overheatingthereof. Sensor 232 is preferably a non-contact sensor such as apyroelectric sensor (for example, IRA-E700ST0 from Murata) or athermopile (such as ST25T0-18 from Dexter Research, Dexter, Mich.) or aconventional temperature monitoring device such as a thermocouple, athermistor, a fiberoptic thermal sensor, or a digital temperature sensor(such as a Dallas Semiconductor DS-18620). In addition to temperaturesensors 232 and 234, temperature sensors 310 may be mounted on the frontor back surfaces of scleral shield 300, as shown in FIGS. 3, 7A-H and 8,to monitor the inner eyelid surface temperature and eyeball temperature,respectively. A threshold temperature may be programmed into the device200, such as 40° C., 45° C. or 50° C. In some embodiments, when thethreshold temperature is reached or exceeded, the safety sensor may beconfigured to shut off the device 200 and/or via safety warningapparatus 240 to signal the user or clinician to stop treatment usinglights, beeps or other notification means. In some embodiments, when thethreshold temperature at any particular location is reached or exceeded,the controller 212 (or discrete circuitry independent of any controller)may be used to prevent heating of the eyelid beyond this thresholdtemperature. This can be accomplished, for example, by shutting off thedevice 200, by reducing the energy being delivered (such as reducingintensity of the light, pulse-width modulation of the LEDs, reducingpower input for ultrasound or RF energy, etc.), or by activating coolingmeasures to reduce eyelid temperature.

A second type of safety sensor is also illustrated in FIG. 10. This mayinclude a single sensor or a plurality of sensors. The purpose of thesecond type of safety sensor is to ensure that the device 200 isproperly positioned against the eyelid prior to activation of thetreatment. The second type of safety sensor can include one or more ofthe following sensors. One sensor can be a light sensor 236. When thedevice is positioned against the eyelid, ambient light is blocked. Thus,the absence of such light can be detected. Alternatively, a reflectiveoptocoupler-type device can be used in which a light source is directeddistally and is coupled with a sensor also aimed distally. This allowsthe presence of the patient to be detected, together with anapproximation of the distance to the patient. Depending on the distancebetween the light source and the optocoupler-type device, lightdetection is either maximized or eliminated when the device 200 isproperly positioned. Another light-detection scheme is to provide alight sensor 236 facing distally toward the patient but outside of thepath of the treatment light. When the device 200 is spaced from theeyelid, reflected treatment light can reach the sensor 236, but whenproperly positioned, most such light is blocked from the sensor 236. Thelight sensor approach can be coupled with data from one of thetemperature sensors to simultaneously detect light and skin temperatureas an indication of the positioning of the device. In any of the lightdetection embodiments, an ambient light sensor 236 can be incorporatedinto the device 200 to measure ambient light levels to facilitate theoptical detection of proximity to the eyelid. Similarly, when using atemperature sensor in conjunction with the second type of sensor, anambient light sensor 236 can facilitate determining when the device 200is against the skin, particularly in a high temperature environment.Other distance or contact detection elements, such as an ultrasonicrange-finding module, can also be used. In some embodiments,thermocouples or thermistors 234 on, in or adjacent to the energytransmission surface may be used to indicate when the device is properlypositioned adjacent to a patient's eye. For example, the thermocouplesor thermistors 234 may register room temperature prior to placement ofthe device adjacent to the eye, and as the energy transmission surface140 comes in proximity to the eyelid skin, the thermocouples orthermistors 234 will register a value closer to body temperature, andtherefore, confirm proper positioning. A reflective or color sensor 237may also be incorporated into the device to confirm that the eye isclosed. As described above, such sensors 237 can provide data indicatingwhether or not there is tissue that appears to be eyelid skin (e.g.,flesh colored and not wet or shiny) or eye tissue (white or iriscolored, and wet and shiny).

In another embodiment, the second type of sensor can be a touch sensor,detecting when the device 200 is touching the face. The touch sensor canbe a resistive sensor, utilizing two electrodes and sensing amicrocurrent through the skin, or a conventional resistive touch sensor.Alternatively, a capacitive sensor can be used to detect when the device200 is touching the skin. This can be either a single sensor or, for abetter signal, a plurality of sensors wherein all or a subset of themmust be activated to allow the treatment to proceed. Finally, the touchsensor can comprise an electrical switch (such as a microswitch) or astrain gauge that is activated when the device is pressed against theskin. For example, the microswitch can be embedded behind a flexible,sealed surface, or it can be activated when sufficient pressure isapplied to allow a first part of the device 200 to move with respect toa second part of the device 200.

A third type of safety sensor may also be used in the device 200 tomonitor the energy delivery transducers to assure proper operationwithin predetermined parameters. Again, this may be a single sensor orcombination of sensors, including one or more of the following. In someembodiments, the safety sensor can measure current and/or voltageapplied to a transducer, as shown in FIG. 10 as transducer monitor 246.Thus, when the transducer is one or more LED emitters 207, the drivecurrent or forward voltage of the LEDs can be monitored, where deviationfrom pre-established parameters can indicate failure of an LED or LEDdriver or unsafe operating conditions. The voltage across an RF orultrasound transducer can similarly be monitored by transducer monitor246, as can the current supplied thereto. In another embodiment, athermal sensor such as thermocouple or thermistor 234 shown adjacent toenergy transducer module 120 in FIG. 10 may be configured to monitor theinternal or external temperature of a transducer element, whereinoverheating can indicate unsafe operation or failure of an element, andlack of heating may also be indicative of an operational failure.

In some embodiments, the controller 212 may be a manual, or open-loopsystem, with autonomous discrete analog and digital circuitry for manualoperation without any automatic control. The manual operation mayinclude turning the device 200 on and off, and receiving safety andfeedback information. In this case, the device 200 is operated manuallywithout a controller by the user or clinician turning the device 200 onand assessing desired treatment of the eyelid using the feedback andadjusting the process in response to the assessment. The feedbackfeatures may signal the user or clinician of the status, such as on/off,lights or beeps, temperature data, pressure data, safety data, or otherdata that could help the user or clinician assess the process. In someembodiments, the controller 212 may include direct-acting thresholddetectors and shut-off circuits for safety. In some embodiments, thecontroller 212 may include a processor or centralized controllerconfigured to monitor the process with feedback features and someportion of the feedback is returned to the controller for safety, suchas turning the system off in an unsafe condition.

The controller 212 functional block encompasses and performs bothoperational functions, to direct the intended operation, and safetyfunctions, and to interface with the various safety sensors 230. It canbe a single processor controlling all functions, i.e., one controller212 as illustrated in FIGS. 3 and 4A, or can comprise two or morecontrollers, such as a primary controller with a secondary safetycontroller acting as a watchdog on the first controller, as iswell-known to those skilled in the art. Specifically, the secondarysafety controller may be designed to monitor the functionality of theprimary controller—if one or more parameters indicate the primarycontroller 212 may not be functioning properly, the secondary safetycontroller is configured to power down the energy transducer and/or theentire device 200. The functions associated with controller 212 can beaccomplished with a controller such as a microprocessor ormicrocontroller with associated software, but certain embodiments maypreferably operate without a controller, and instead utilize one or moreof a programmable gate array, a logic array, analog circuitry, digitalcircuit elements, or any combination of the foregoing.

In one simple embodiment, the secondary safety controller comprises anarray of analog or digital circuit elements without a processor. Forexample, optical, temperature, and/or pressure switches either hardwired together or with logic circuitry, op amps, and/or relays areconfigured to allow initial or continued operation of the device only ifthe sensors are in a predetermined state. In an alternative embodimentillustrating full processor control, all sensors are monitored throughdigital or ADC inputs to one or more programmed processors to performthe functions of a second safety controller and to either preventoperation outside of predetermined parameters or to modulate theoperation of active elements in the device 200 to stay within thoseparameters.

In addition to safety functions, the controller 212 may direct thenormal operation of the device 200. For example, it can interface withthe user through a user interface 270 which may include control buttons,rotary encoders, touch screens, voice commands, or any otherconventional user interface. It can control a power manager, direct orinterrupt current flow to the energy transducer and modulate its output,initiate or stop operation of the vibration apparatus, initiate ordisable a safety warning, initiate, modulate, or stop operation of thesurface cooling apparatus, and monitor and modulate cooling of theenergy transducer through the thermal manager. The controller 212, orthe discrete circuit substitute, may be operationally linked to some orall of these systems within the device 200. In addition, it can includea timer function to automatically shut off the energy transducer andthus interrupt delivery of heating or vibrational energy to the eyelidafter a predetermined period of operation, or in response to signalsfrom the first, second, or third type of safety sensors.

The power source module 110 is designed to facilitate supply of power tothe device 200. It can include external power interfaces, such as cordsor cables interconnecting with an external power source. In a preferredembodiment, the power manager includes an internal power supply. In someembodiments, the power manager includes a rechargeable battery orbattery pack. This could include nickel-metal hydride batteries, lithiumion or lithium polymer batteries, nickel cadmium batteries, or any othersuitable rechargeable or non-rechargeable batteries. The batteriespreferably provide a high current capacity, such as 1-5 amps, preferablyat least 3 amps surge current, with the ability to deliver such highcurrent for 1, 2, 3, 4, 5, or more minutes. In some embodiments, theinternal batteries deliver 3, 4, 5, 6, 7, 8, 9, 10, or 12 volts or more.The capacity of the batteries is dictated by the design load, and maybe, for example, a battery pack having at least a 200, 300, 400, 500,1000, 2000, 2500 mA-hour capacity or more. The desired voltage can beaccomplished by connecting lower voltage batteries in series to achievethe desired voltage, or through use of a DC:DC converter to step up alower voltage to the desired voltage. In some embodiments, the batteriessupply a voltage lower than that required by the energy transducer powersupply, and the voltage is stepped up for the energy transducer while alower voltage, e.g., 5V or 3.3V, is supplied to the controller 212 oralternative discrete circuitry.

In one preferred embodiment, the energy transducer may be a high-powerLED similar to one made by LED Engin, Inc.; specifically, the energytransducer may be an LZ9 configured with nine green emitters in anon-standard configuration arranged as three sets of three seriesemitters in parallel, requiring approximately 12-14V forward voltage andup to 2.4 amps for maximum illumination. In this embodiment, threeRCR123 LiFePO4 cells or similar may be utilized in series, having acapacity of 750 mA-hours and providing a starting voltage of 7.2V. ADC-DC converter circuit is included which boosts the voltage byapproximately two times in order to provide the voltage needed to drivethe LED.

Power management functions can include a charger, battery statusmonitor, and/or temperature monitor. These functions can be performed byseparate circuitry or incorporated in whole or in part into thecontroller 212. In some embodiments, power management includes a batterycharger powered through inductive coupling to an external power supply,which can allow the device 200 to be sealed, allowing easy cleaning andpreventing ingress of moisture or dirt. In some embodiments, theinductive coupling may use a recharging cradle or electrically-isolatedmains power connection. The inductive coupling may include two inductioncoils in close proximity (one in the cradle and one in the device) ortwo coils tuned to resonate at the same frequency (resonant inductivecoupling or electrodynamic induction).

Thermal management is also a critical element of many preferredembodiments, including, in some cases, heat removal from the energytransducer, such as an LED or LED array. In the case of LEDs, it isimportant to maintain the junction temperature below a predeterminedthreshold, such as 135 degrees Celsius. Other transducers similarly havemaximum allowable component temperatures, and proper thermal managementhelps maintain those components within allowable temperatures. Forexample, heat sinks thermally coupled to the energy transducer elements,fans, radiators, cooling fluids, and the like may be utilized. In apreferred embodiment, the device 200 is sealed and a thermal managementstructure 220 such as shown in FIG. 9 directs excess heat to an externalsurface of the device 200. This allows for a sealed device withoutventilation openings. In other embodiments, a cooling fluid is directedfrom the thermal manager inside the device to remove heat from thedevice, such as through forced air cooling (as shown or FIG. 8), or aliquid-cooled radiator.

In a further aspect of the technology, the device 200 may includeelements useful in calibrating the device so that it provides thedesired amount of heating to target tissue over a wide range of eyelidthicknesses. This is important because without such calibration, theamount of heating that occurs at the target tissue region (e.g., themeibomian glands and adjacent tissue) can vary unless the temperaturenear the target tissue region is measured during the treatment. Asdiscussed previously, monitoring of the target tissue region may beaccomplished by use of a scleral shield, or the like, equipped withtemperature sensors. However, it may be inconvenient for users of thedevice to insert scleral shields each time they use the device.Therefore, it may be useful to calibrate each device to an individual'sspecific anatomy. To accomplish that, the device may be calibrated byusing a scleral shield initially, preferably in the setting of an eyecare professional's office, and in conjunction with an external monitorand calibrator.

For example, with reference to FIG. 13, as the device 200 applies energyto the eyelid(s), the scleral shield 300 transmits temperature data(either through a wired or wireless connection) to an external monitorand calibrator 500. The external monitor and calibrator 500 tracks therate of temperature rise over time, and thereby characterizes theheating profile of the patient's eyelid(s). With that data, the externalmonitor and calibrator 500 can then program the device 200 to heat thetarget tissue to the desired temperature range. In a simple embodiment,the external monitor and calibrator 500 turns on the energy transducer,measures the amount of time needed for the target tissue to reach thedesired temperature, and then turns off the energy transducer andprograms the device 200 to apply energy for that same amount of time.Alternatively, the device 200 may be programmed to provide increased ordecreased amounts of energy in order to heat the target tissue to thedesired temperature within a preferred period of time. In mostindividuals, eyelid thickness is similar from upper eyelid to lowereyelid and from the right eye to the left eye, however, it will beappreciated that the external monitor and calibrator may separatelymeasure and separately program the device to apply specific amounts ofenergy to each individual eyelid in order to ensure proper heating ofeach one. It will be further appreciated that there may be variances inthe performance of the components used to implement the energytransducer and related circuitry, and that, without proper calibration,one device might produce more or less energy than another. One solutionto this is for the factory to measure the actual energy output for agiven command level from the controller, and to incorporate acalibration table within the controller, such that every device 200 putsout an equal amount of energy for a given command level. Alternatively,and additionally, with the external monitor and calibrator 500, suchvariances can also be compensated for by the procedure described above,wherein the ultimate goal of the device 200 is to heat target tissue toa desired temperature, and each device 200 is programmed to do so(regardless of component variances) on each specific patient (andoptionally on each specific eyelid).

Referring now to FIGS. 14A and 14B, in one embodiment of the scleralshield 300, there is an array of temperature transducers 310 embedded inthe shield. For this application, where the shield is not actually beingused to shield the eye from the energy, but instead to measuretemperatures, the shield 300 may be made of materials that aresubstantially transparent to the energy emitted from the energytransducer. By way of specific example, if the energy transducer is alight source, the shield 30 may be made of a clear material that passesthe wavelength(s) of light emitted by the energy transducer. Preferably,the shield 300 is also as thin as possible and supple, with no sharpfeatures, so that it can comfortably be placed under the eyelids withminimal discomfort to the patient and so it has a minimal effect on theheating of the tissue. In the embodiments shown in FIGS. 14A and 14B, anexample is shown wherein there is an array of six temperature sensors310 on a front face 302 of the shield 300, and an array of sensors onthe back face 304. This configuration allows the front-facing sensors312 to more directly measure the temperature of the tissue on the insidesurface of the eyelids, where the meibomian glands are located, whilethe back-facing sensors 314 more directly measure the temperature of thesurface of the eye, along the midline of the central ocular axis, wherethe most sensitive eye tissues are nominally located. The temperaturesensors may be discrete elements (such as thermocouples made from veryfine wire, or miniature thermistors) embedded in the shield 300, or theymay be thermocouples formed by depositing thin films of appropriatemetals onto intermediate layers of the shield 300. In some embodiments,the preferred types of materials for the shield 300 are soft, flexible,biocompatible materials such as silicone, polyurethane, and varioushydrogels similar to those used in contact lenses.

While the above embodiments describe the configuration having andexternal monitor and calibrator 500, it will be appreciated that thedevice 200 itself can have the same capability built into it, in whichcase the scleral shield 300 communicates temperature data directly tothe device 200, and the device 200 programs itself to provide thecorrect treatment profile for that particular patient (and optionallyfor individual eyes and eyelids). In such embodiments, the device 200has a sophisticated user interface 270 allowing the clinician to commandthe device 200 to perform a calibration sequence, and optionallyinstruct the device 200 as to which eye and/or eyelid is beingcalibrated. It is appreciated that if the device 200 is calibrated toprovide individually calibrated treatment to each eye or eyelid, thedevice 200 needs to be able to indicate (via a series of lights or analphanumeric or graphical display) to the patient which eye or eyelid isto be treated next.

Alternatively or additionally, a calibration element may be used tomeasure the energy output of the device 200. For embodiments where theenergy transducer is a light source, the calibration element may be alight meter to measure, for example, luminous flux, lumens or radiantflux. For embodiments where the energy source is an ultrasonictransducer, the calibration element may be an ultrasonic energy meter.The calibration element may be used to determine if the device 200 isoperating within acceptable limits or not, and may also provide data toallow adjustment of certain parameters (such as energy level ortreatment time) to bring the device 200 back into the desiredperformance range. It will be appreciated that the calibration elementmay also communicate directly with the device 200 or indirectly (e.g.,through a PC) with the device 200 in order to reprogram the device 200with updated calibration data to keep the device operating within anacceptable performance range.

In some embodiments, the device 200 may further include a temperaturedisplay feature or dashboard 218 for the in-office device, which couldinclude inner lid and outer lid temperatures. The temperature displayfeature may display absolute temperatures, or just relative temperaturesversus a maximum. For example, the temperatures may be displayed in abar graph format or with one or more lights.

In some embodiments, the device 200 may further include a dataloggingfeature 214 configured to record aspects of the treatment, (e.g., time,date, usage parameters, temps, photos, videos, etc.). In someembodiments, the device 200 may further include a voice recordingfeature 213 so clinicians can record verbal observations of how many MGsare healthy, clogged, atrophied, etc., along with time, date and patientname. This allows the clinician to carry out the procedure without theneed to take manual notes and/or without the need to have an assistantpresent. In some embodiments, the device 200 may further include acommunication means configured to couple with an external PC, tablet orsmartphone for downloading data, voice recordings, camera images orvideo clips.

FIGS. 15A-15D show another embodiment of an eye treatment device 200positioned relative to an eyeball 20 for treatment of the eyelid 14 forMGD, blepharitis and other medical conditions. In some embodiments, theeye treatment device 200 is configured to heat the inner and/or outersurfaces of the eyelid while compressing the eyelid, similar to theembodiment of FIG. 3. As the heat from the eye treatment device 200 istransmitted to the eye system 10, particularly to the treatment tissuesuch as the meibomian glands 18, the heat can soften the meibum andthereby allow the meibum to be more readily expressed during massage oreye exercises. The eye treatment device 200 can include configurationsof the modules depicted in FIGS. 2A-2H and FIG. 3, along with additionalcomponents useful in operation of the eye treatment device 200.

The eye treatment device 200 can include a housing 202 having a proximalportion 201 and a distal portion 203 coupled with a removable orconsumable portion 260. The housing 202 may include a power sourcemodule 110, a controller 212, an energy transducer module 120, and anenergy transmission surface 140. The energy transducer module 120 ofsome embodiments may include an LED device formed of one or more of anLED emitter 207, a thermal management structure 220, and an energytransducer module driver 209. The energy transmission surface 140 andLED emitter 207 are positioned near a distal end 203 of the housing 202and are in a slidable relationship along movement path 145 with energytransducer module 120 using lever 182, which allows for the energytransmission surface 140 to move with the LEDs 207 simultaneously.

The housing 202 may further include visualization means 160 for enhancedmonitoring of the eyelid margin during diagnosis and treatment, adisplay or dashboard 218 showing various temperatures of the eyelid,such as inner and/or outer surface temperatures, a datalogger 214,and/or voice recorder 213, and circuitry for communication betweendevice and consumable circuitry in order to identify the type ofconsumable, ensure that the consumable is in proper alignment and/orprevent reuse of the consumable.

The consumable portion 260 may include a scleral shield 300, asdiscussed above, that can be positioned between the eyelid 12, 14 andeyeball 20 to cover sensitive anatomy of the eye system 10 (such shownin FIG. 1). The scleral shield 300 may be coupled to the housing 202with one or more support arms 262, with the wires being positioned on orwithin the arms, and, in certain embodiments, with the structuralportion of support arms 262 made from insulating materials surroundingor otherwise channeling the conductive portions of wire or wire array420

The eye treatment device 200 can include a power source module 110 forproviding power to the various components of the eye treatment device200 and may be electrically coupled to some or all of the components. Incertain embodiments having a controller 212, the controller 212 canreceive input instructions from a user (for example, through a userinterface device 270, such as a button, switch, touch screen, voicecommands, from another module or device, such as a smartphone) to emitlight from the LED emitter 207.

The LED emitter 207 is a part of one type of energy transducer module120 that can be configured to emit light of the appropriate wavelengthnecessary for the desired treatment. The treatments may include one ormore of the following: diagnosing the eyelids 12, 14 by the illuminatingthe inner and/or outer surfaces, eyelid margins, and/or the meibomianglands behind the eyelids; heating the target tissue region of the eyesystem 10 (e.g., the meibomian gland behind the eyelids 12, 14); andantibacterial treatment to kill bacteria in the eye system 10.

In some embodiments, an additional shielding element 258 may be used toprevent unwanted photonic energy (such as IR or blue/violet light) fromreflecting off the transillumination element back to the clinician.

A feature of many of the embodiments disclosed herein is the ability ofthe clinician to view the eyelid margin during the application of heatand compression. By viewing the margin, the clinician can see whatcontents, if any, are being expressed from the meibomian ducts, andthereby adjust the amount of heating and compression applied to theeyelid being treated in order to optimally unclog blocked meibomianglands. By way of example, a clinician may observe at the start of atreatment that certain meibomian glands in the portion of the eyelidbeing treated have a clear oily discharge, which signals normal glands.In contrast, some glands may secrete a cloudy oily discharge, or smallamounts of thick, toothpaste-like lipid, both of which signal adysfunctional gland. As the clinician applies heat and compression tothe portion of the eyelid being treated, further observation of thedysfunctional glands can show that the cloudy or thick secretions changeto clear, and the amount of discharge may suddenly increase, indicationthat the gland or glands have been unclogged. At such point, theclinician may reduce the heat and compression applied to that region,since the treatment has successfully unclogged the blocked glands.Without this continuous visual feedback, the clinician would berelegated to applying a standard treatment regimen, which may either beunder- or over-aggressive for the particular clogged gland(s) in a givenpatient.

By way of reference, at least FIGS. 2D, 2E, 2F, 2G, 2H, 3, 15A, 15B and15D each show example of embodiments wherein the eyelid margin isexposed for a clinician to visually monitor during treatment. Theclinician would be positioned in front of the eye being treated.

Referring now to FIG. 16A, a side cross-sectional view is shown of anenergy transmission surface 140, an eyelid 14 with an eyelid margin 14a, a scleral shield 300, and a visualization means 160 with optical path175. This embodiment is the same as is shown in FIG. 2E, except withoutimage translator 155. In the embodiment of FIG. 16A, the visualizationmeans is directly focused on eyelid margin 14 a, and more specificallyon meibomian ducts 19.

FIG. 16B is a front perspective view of the same embodiment of FIG. 16A,showing an example where eyelid 14 is compressed between energytransmission surface 140 and scleral shield 300, while eyelid margin 14a is viewable from the front by a clinician. This embodiment is the sameas shown in FIG. 2F without image translator 155.

FIG. 16C is a similar embodiment as shown in FIG. 16A, with the additionof support arm 262. Support arm 262 is the same as shown in FIGS. 3, 3A,7H, 7G, and 15B.

FIG. 16D is a front perspective of the embodiment shown in FIG. 16C,showing a pair of support arms 262 coupled to scleral shield 300. Eyelidmargin 14 a is exposed, and is adjacent to the bottom edges of supportarms 262, by way of example but not limitation. FIG. 16E is the same asFIG. 16D but with aperture 440 for viewing the eyelid margin 14 ahighlighted by the bold dotted rectangle. FIG. 16F is a top view of theembodiment of FIGS. 16D and 16E, showing energy transmission surface 140compressing the eyelid against scleral shield 300, with eyelid margin 14a exposed for visual monitoring. FIG. 16G is the same as FIG. 16F butwith aperture 440 for viewing the eyelid margin 14 a highlighted by thebold dotted rectangle. In an embodiment, the distance between the armsis between 0.2 inches and 1.2 inches. In an embodiment, a distancebetween a line defined by the points of attachment between the two armsand the back plate and a line defined by the points of attachmentbetween the two arms and compression element is at least 0.04 inches.

FIG. 16H is a more detailed side cross-sectional view of the embodimentof FIG. 16C, further defining the boundaries of aperture 440 in certainpreferred embodiments. In the figure, Line 1 indicates the lower(horizontal) boundary of the aperture, and Line 2 defines the upper(vertical) boundary. Angle 1 is the angle between Lines 1 and 2, and istheoretically about 90 degrees, although variations in the anatomy ofcheekbone and eyebrow structure may result in variations in theseboundaries. FIG. 16J is a more detailed depiction of the embodiment ofFIG. 16H, wherein the preferred lower boundary of aperture 440 is shownas Line 4 and the preferred upper boundary of aperture 440 is shown asLine 6. Angle 2 is the angle between horizontal Line 3 and Line 4, andis preferably between about 5 and about 20 degrees, while Angle 4 isbetween Lines 3 and 6, and is preferably between about 60 and 80degrees. Angle 3 is the angle between Line 3 and Line 5 and is apreferred angle of viewing of eyelid margin 14 a through aperture 440,and is preferably between about 25 and 50 degrees.

FIG. 16K depicts an embodiment similar to 16H, except energytransmission surface 140 is shorter than that shown in FIG. 16H, therebyexposing more of the upper part of eyelid 14 adjacent to eyelid margin14 a. In this embodiment, aperture 440 is larger, although the outerboundaries defined by lines 7 and 8 are parallel to those defined byLines 1 and 2 in FIG. 16H, and Angle 5 between them is therefore alsoabout 90 degrees.

FIG. 16L is similar to the embodiment shown in 16K, except scleralshield 300 extends behind both the upper and lower eyelid, and there areportions of energy transmission surface 140 that are adjacent to uppereyelid 12 as well as lower eyelid 14. In this embodiment, both the upperand lower eyelids are being heated and compressed instead of just thelower eyelid. As shown, support arm 262 is linked to scleral shield 300,and energy transmission surfaces 140 are configured so as to allowviewing of both the upper and lower eyelid margins through aperture 440.Lines 9 and 10 depict the approximate lower and upper limits of aperture440, thereby defining Angle 6, which is preferably between about 10 and150 degrees, and more preferably between about 20 and 120 degrees. Itwill be appreciated that many modifications to the embodiments hereindisclosed are possible, some of which may alter the optical path andthereby change the angles associated with the aperture. For example, animage translator such as that shown in FIG. 2E may be employed, as mayother means of reflecting, guiding or translating the image of theeyelid margin through an aperture to a clinician. Alternatively, theaperture may be an optically transmissive window through a structuralelement. For example, in FIG. 16L, energy transmission surface 140 maycompletely cover both the portions of the upper and lower eyelids beingtreated, and instead of there being an opening near the eyelid margin,at least a segment of surface 140 may be transparent enough for aclinician to view the eyelid margin. Further, there could be an imagesensor, fiberoptic bundle or light pipe mounted adjacent to, or directedat, the eyelid margin, and the image of the eyelid margin could betransmitted electronically or optically to a point outside the surface140. All of these alternate embodiments, and others apparent to thoseskilled in the art, are included within the scope of this disclosure.

FIG. 16M shows the embodiment of FIG. 16L in a front perspective view.As shown, dual support arms 262 are linked to scleral shield 300, anddual energy transmission surfaces 140 are shown adjacent to the uppereyelid 12 and lower eyelid 14. As shown, the upper and lower eyelidmargins, 12 a and 14 a, respectively, are visible, and meibomian ducts19 are visible as well. FIG. 16N is the same as FIG. 16M, with aperture440 generally defined by the bold dotted rectangle shown.

FIG. 16P is similar to the embodiment of FIG. 16M, but with a singlesupport arm 262. FIG. 16Q is the same as the embodiment of FIG. 16P buthighlighting the two apertures 440 defined by the gaps between the upperand lower energy transmission surfaces 140, and to the right and left ofcentral support arm 262. Other combinations of single or multiplesupport arms or other structures having single or multiple apertures maybe contemplated by those skilled in the art.

It will be appreciated that FIGS. 16A-Q show the unique configuration ofthe energy transmission surfaces 140, the scleral shields 300 andsupport arms 262, which define an aperture 440 that allows viewing ofone or both eyelid margins during the application of heat andcompression to the portion of the eyelid being treated. Many otherconfigurations are possible and only a few exemplary embodiments havebeen described herein to demonstrate the innovative concept.

Referring now to FIG. 17A, an assembly is shown similar to portions ofthe embodiment shown in FIG. 3. Energy transducer module 120 ispositioned adjacent to the proximal end of energy waveguide module 130.The distal end of module 130 is adjacent to energy transmission surface140, made up of face glass 284 (shown in FIG. 17C) and single-use coverelement parts 147 a and 147 b. Part 147 b abuts eyelid 14. FIG. 17B is afront view of energy transducer module 120, consisting of two infraredLEDs 120 a and four lime emitting LEDs 120 b, all mounted on asubstrate. FIG. 17C is an exploded view of the same components describedin FIGS. 17A-B, including a call-out 130 a for the inside surface ofenergy waveguide module 130. In some embodiments, waveguide module 130may be in a fixed relationship with module 120, while in otherembodiments, module 130 may slide with respect to module 120, and inothers module 120 may slide with respect to 130. In a preferredembodiment, module 120 is fixed and module 130 slides back and fortharound module 120. In such a preferred embodiment, when module 130 isfully advanced, it pushes energy transmission surface 140 against eyelid14 (or 12, when treating an upper eyelid).

In order to maximize the efficiency of transmitting light energy frommodule 120 to surface 140, the inner surface of module 130 may be coatedor lined with a material that is highly reflective to the wavelengthsemitted by module 120. By way of example, the inner surface of module130 may be coated with a protected silver material, or it may be linedwith films such as WRF-150 from Fusion Optix, or ESR film from 3M, allof which are designed to provide >97% reflection of the wavelengthsbetween 500 nm and 900 nm.

In certain embodiments, part 147 a may be fabricated from a plastic orglass material that transmits light energy in the 500-880 nm range.Acrylic is one example of an acceptable material for part 147 a. Part147 b is preferably a low durometer material such as silicone in orderto provide a soft surface to press against the surface of the eyelid.Since most silicones are not fully transparent to infrared energy, it ispreferable to keep the thickness of 147 b in the range of about0.02-0.06 inches in order to minimize energy loss.

FIG. 17D shows the distribution of infrared energy transmitted througheyelid 14 when module is fully advanced (with its distal end about 0.5inches from the highest point on the infrared LED lens). Referring tothe graph shown in the upper left, the darker regions are the areas ofhighest irradiance (Watts per square millimeter), while the lighterregions are the lowest irradiance. As shown, the highest irradianceoccurs near the middle, and the irradiance drops off sharply toward theedges. The asymmetrical distribution across the X axis is not ideal,since it is desirable to heat the eyelid tissue evenly across from oneedge to the other. In the Y-axis direction, some asymmetry is desirable,since most of the blockages that occur in a meibomian gland are near theorifice or duct. In the case where a lower eyelid is being treated, andthe top edge of module 140 is aligned with the top edge of the lowereyelid, it would be preferable to have the irradiance profile (andtherefore the tissue heating profile) be biased toward the top edge,while also warming the overall eyelid.

In order to improve the distribution of irradiance of the infraredlight, a partially reflective coating 196 may be applied to a surface ofpart 147 a, as shown in FIG. 17E. In one embodiment, this coating is anapodization coating which transmits about 33% and reflects about 67% ofthe energy in the 820-880 nm range. FIG. 17F shows a more detailed viewof the coating pattern, with two zones 196 a and 196 b shown. FIG. 17Gshows the resulting distribution of irradiance through the eyelid whenthe apodization coating is utilized. As shown, the highest irradiancezone is much wider and is skewed toward the top edge, and there is muchless drop-off in irradiance toward the right and left ends along the topedge. As such, there will be preferential heating of tissue along theupper half of the eyelid (in the case of treating a lower eyelid), andthe heating from left to right across the eyelid is more uniform.

If the apodization coating 196 is also reflective of wavelengths in thelime region (500-600 nm), then very little lime light will reach thedesired parts of the eyelid, and there will therefore be less heating ofthe eyelid tissue through chromophore absorption of the lime lightenergy. To address this, in one embodiment, it is preferable for coatingregion 196 a to be partially reflective only for infrared only (67%reflective, 33% transmissive for 820-880 nm; >90% transmissive for lime500-600 nm), and for coating region 196 b to be partially reflective(67% reflective, 33% transmissive) to both infrared (820-880 nm) andlime (500-600 nm).

FIG. 17H shows a lime irradiance distribution plot on the surface of theeyelid for an embodiment having an apodization coating as describedabove (zone 196 a transmits lime and partially reflects infrared, andzone 196 b partially reflects both). As can be seen, the irradiancepattern is preferentially skewed to the upper half of the eyelid and iswell distributed from the right to left end, without significantdrop-off in irradiance.

It will be appreciated that the examples of coating types and depositionpatterns disclosed herein are simple examples to demonstrate theinvention and that alternate configurations may result in more evendistribution of irradiance in the desired spectra. For example, anothermethod of shaping the heating pattern of the eyelid is to modify thedeposition pattern or properties of the energy absorbing surface 302 ofscleral shield 300 (as shown in FIG. 3A). For example, in order to evenout the heating of the scleral shield if the irradiance pattern is asshown in FIG. 17D, the right and left portions of the surface of scleralshield 300 may be more densely coated with energy-absorbing materialthan the central portions of scleral shield 300. Further, in order toskew the heating toward the upper portion of the eyelid, the upperportion of the surface of the scleral shield could be more denselycoated with energy-absorbing material. Combinations of coatings onelements within the energy transmission path as well as alterations ofthe energy reflecting and absorbing properties of the surface of thescleral shield are all included within the scope of the invention.

For purposes of summarizing the disclosure, certain aspects, advantagesand features have been described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, the invention may be embodied or carriedout in a manner that achieves or optimizes one advantage or group ofadvantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

While this invention has been described in connection with what arepresently considered to be practical embodiments, it will be appreciatedby those skilled in the art that various modifications and changes maybe made without departing from the scope of the present disclosure. Itwill also be appreciated by those of skill in the art that parts mixedwith one embodiment are interchangeable with other embodiments; one ormore parts from a depicted embodiment can be included with otherdepicted embodiments in any combination. For example, any of the variouscomponents described herein and/or depicted in the Figures may becombined, interchanged or excluded from other embodiments. With respectto the use of substantially any plural and/or singular terms herein,those having skill in the art can translate from the plural to thesingular and/or from the singular to the plural as is appropriate to thecontext and/or application. The various singular/plural permutations maybe expressly set forth herein for sake of clarity.

While the present disclosure has described certain exemplaryembodiments, it is to be understood that the invention is not limited tothe disclosed embodiments, but, on the contrary, is intended to covervarious modifications and equivalent arrangements included within thescope of the appended claims, and equivalents thereof.

1-17. (canceled)
 18. A system for treating meibomian gland disease in atleast a portion of an eyelid by a clinician, comprising: a back platesized to be positioned between an eyeball and an eyelid of a patient; acompressive element mechanically linked to the back plate, thecompressive element positionable adjacent to the outer surface of theeyelid while the back plate of the treatment device is positionedbetween the eyeball and the eyelid, wherein the back plate and thecompressive element collectively define an aperture between the backplate and the compressive element such that the aperture provides a lineof sight that permits viewing of an eyelid margin by the clinicianthrough the aperture when the backplate is positioned between an eyeballand an eyelid of a patient; a light-emitting device that emits lightenergy, the light-emitting device positionable outside of the eyelidwhile the back plate is positioned between the eyeball and the eyelid,wherein the light-emitting device can emit light to heat tissue of theeyelid adjacent to the meibomian glands of the patient to a temperaturesufficient to melt or soften meibum of the meibomian glands; a housing,wherein the back plate, the light-emitting device, and the compressiveelement are mechanically coupled to the housing.
 19. The system of claim18, wherein the compressive element is mechanically linked to the backplate such that the compressive element is slidable along a movementpath relative to the eyelid and the back plate when the backplate ispositioned between an eyeball and an eyelid of a patient.
 20. The systemof claim 18, wherein the compressive element can compress a portion ofthe eyelid without obstructing the clinician's view of the eyelid marginadjacent to a compressed eyelid portion when the backplate is positionedbetween an eyeball and an eyelid of a patient.
 21. The system of claim18, further comprising a magnifying lens coupled to the housing.
 22. Thesystem of claim 21, wherein the compressive element, magnifying lens,and the back plate are connected to a single housing.
 23. The system ofclaim 21, wherein the back plate and the magnifying lens aremechanically connected to maintain a fixedly spaced relationship. 24.The system of claim 21, wherein the back plate and the magnifying lensare mechanically connected to maintain an adjustably spacedrelationship.
 25. The system of claim 21, wherein the compressiveelement and the magnifying lens are mechanically connected to maintain afixedly spaced relationship.
 26. The system of claim 21, wherein thecompressive element and the magnifying lens are mechanically connectedto maintain an adjustably spaced relationship.
 27. The system of claim18, further comprising a camera and a display.
 28. The system of claim18, wherein the housing is a handheld housing.
 29. The system of claim18, wherein the back plate is rigidly linked to the housing and thecompressive element is movably linked to the housing.
 30. The system ofclaim 18, wherein the compressive element is rigidly linked to thehousing and the back plate is movably linked to the housing.
 31. Thesystem of claim 18, wherein the both the compressive element and theback plate are movably linked to the housing.